FDA 510(k) Applications for Medical Device:
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K032108 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K171365 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K152252 | ARTHREX, INC. |
1370 CREEKSIDE BLVD | NAPLES | FL | 34108-1945 |
| K141635 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K153586 | Arthrex, Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K041872 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K083782 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K060303 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K122160 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46582 |
| K053505 | BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K061433 | BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K033489 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K080361 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K140883 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K050222 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K141407 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K132873 | BIOMET, INC. |
56 EAST BELL DRIVE | WARSAW | IN | 46581 |
| K153657 | BIOMET, INC. |
56 EAST BELL DRIVE | WARSAW | IN | 46581 |
| K232426 | Conformis Inc |
600 Technology Park Drive | Billerica | MA | 01821 |
| K223316 | Conformis Inc. |
600 Technology Park Drive, 4th Floor | Billerica | MA | 01821 |
| K102927 | Consensus Orthopedics, Inc |
1115 WINFIELD WAY | EL DORADO HILLS | CA | 95762-9623 |
| K110950 | CONSENSUS ORTHOPEDICS, INC. |
1115 WINDFIELD WAY STE 100 | EL DORADO HILLS | CA | 95762 |
| K140881 | DEPUY (IRELAND) |
LOUGHBEG | CO. CORK | -- | |
| K212746 | Depuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K213781 | DePuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K240678 | Depuy Ireland UC |
Loughbeg, Ringaskiddy | Cork | ||
| K232303 | DePuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K202194 | DePuy Ireland UC |
Loughbeg Ringaskiddy | Co. Cork | ||
| K230295 | DePuy Ireland UC |
Loughbeg, Ringaskiddy | Co. Cork Munster | ||
| K071417 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46582 |
| K062654 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K210308 | Encore Medical, L.P. |
9800 Metric Blvd. | Austin | TX | 78758 |
| K171991 | Encore Medical, L.P. |
9800 Metric Blvd. | Austin | TX | 78758 |
| K212941 | Encore Medical, L.P. dba DJO Surgical |
9800 Metric Boulevard | Austin | TX | 78758 |
| K032905 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K153776 | Exactech Inc |
2320 NW 66th CT | Gainesville | FL | 32653 |
| K240393 | Exactech Inc. |
2320 NW 66th Court | Gainesville | FL | 32653 |
| K140302 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K181794 | Exactech, Inc. |
2320 NW 66th CT | Gainesville | FL | 32653 |
| K182346 | Exactech, Inc. |
2320 N.W. 66th Court | Gainesville | FL | 32653 |
| K043374 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K033972 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K033971 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K061521 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K051380 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K172634 | Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. | Mahwah | NJ | 07430 |
| K032163 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K032418 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K070883 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K200782 | Howmedica Osteonics Corp. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K190991 | Howmedica Osteonics Corp. (aka Stryker Orthopaedics) |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K031462 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K040487 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K243615 | Limacorporate S.p.A. |
Via Nazionale, 52 | Villanova di San Daniele del Friuli | 33038 | |
| K201084 | LimaCorporate S.p.A. |
Via Nazionale 52 | Villanova di San Daniele del Friuli | 33038 | |
| K210554 | Limacorporate S.p.A. |
Via Nazionale, 52 Villanova di San Daniele | Udine | 33038 | |
| K250980 | Limacorporate S.p.A. |
Via Nazionale, 52 | Villanova di San Daniele | 33038 | |
| K140257 | MATERIALISE N.V. |
15 TECHNOLOGIELAAN | LEUVEN | 3001 | |
| K093533 | MATERIALISE N.V. |
15 TECHNOLOGIELAAN | LEUVEN | 3001 | |
| K150680 | MAXX ORTHOPEDICS, INC. |
531 PLYMOUTH RD., SUITE 526 | PLYMOUTH MEETING | PA | 19462 |
| K241597 | Maxx Orthopedics, Inc. |
2460 General Armistead Avenue, Suite 100 | Norristown | PA | 19403 |
| K221850 | Medacta International S.A. |
Strada Regina | Castel San Pietro | CH-6874 | |
| K223548 | Medacta International S.A. |
Strada Regina | Castel San Pietro | CH-6874 | |
| K242412 | Medisurge, LLC |
2140 Oak Industrial Dr. NE | Grand Rapids | MI | 49505 |
| K143366 | MicroPort Orthopedics Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K140735 | MICROPORT ORTHOPEDICS INC. |
5677 AIRLINE RD | ARLINGTON | TN | 38002 |
| K233507 | Microport Orthopedics Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K213817 | MicroPort Orthopedics Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K170288 | MicroPort Orthopedics, Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K152298 | MICROPORT ORTHOPEDICS, INC. |
5677 AIRLINE ROAD | ARLINGTON | TN | 38002 |
| K180317 | MicroPort Orthopedics, Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K080842 | OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE | RAYNHAM | MA | 02767 |
| K240938 | Optimotion Implants LLC |
6052 Turkey Lake Rd | Orlando | FL | 32819 |
| K220049 | Optimotion Implants, LLC |
6052 Turkey Lake Road | Orlando | FL | 32819 |
| K191084 | Optimotion Implants, LLC |
5931 Brick Court, Suite 130 | Winter Park | FL | 32792 |
| K243768 | restor3d, inc. |
4001 NC 54, Suite 3160 | Durham | NC | 27709 |
| K051510 | SIGNAL MEDICAL CORP. |
400 PYRAMID DR. | MARYSVILLE | MI | 48040 |
| K203779 | Signal Medical Corporation |
400 Pyramid Dr. | Marysville | MI | 48040 |
| K032683 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K030612 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K071790 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K211246 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K100897 | SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD | MEMPHIS | TN | 38116 |
| K210566 | Smith & Nephew, Inc. |
1450 Brooks Road | Memphis | TN | 38116 |
| K091543 | SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD | MEMPHIS | TN | 38116 |
| K073325 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K211221 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K030623 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K121393 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K123486 | Stryker |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K122053 | STRYKER CORP. |
1600 HARBOR BAY DRIVE | ALAMEDA | CA | 94502 |
| K110533 | STRYKER CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K141056 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K072575 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K173849 | Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K143393 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K132624 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K162256 | TOTAL JOINT ORTHOPEDICS, INC. |
1567 E. STRATFORD AVENUE | SALT LAKE CITY | UT | 84106 |
| K193312 | Unik Orthopedics, Inc. |
1701 Fortune Drive, Unit E | San Jose | CA | 95131 |
| K140075 | UNITED ORTHOPEDIC CORP. |
NO. 57, PARK AVE 2, SCIENCE PARK | HSINCHU | 300 | |
| K150832 | UNITED ORTHOPEDIC CORPORATION |
NO 57, PARK AVE 2, SCIENCE PARK | HSINCHU | 300 | |
| K221705 | United Orthopedic Corporation |
No 57, Park Ave 2, Science Park | Hsinchu | 30075 | |
| K201364 | Waldemar Link GmbH & Co. KG |
Ostsra▀e 4-10 | Norderstedt | 22844 | |
| K200113 | Waldemar Link GmbH & Co. KG |
Oststrabe 4-10 | Norderstedt | 22844 | |
| K081479 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K043083 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K063128 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K063731 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K061223 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K122218 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K093405 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K103598 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K243293 | Zimmer Biomet |
1800 W Center St | Warsaw | IN | 46580 |
| K123459 | ZIMMER INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K053340 | ZIMMER TRABECULAR |
80 COMMERCE DR. | ALLENDALE | NJ | 07401 |
| K120990 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K102896 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K103517 | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K070214 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K071107 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K072619 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K041100 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K031061 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K072160 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K243247 | Zimmer, Inc. |
1800 W. Center Street | Warsaw | IN | 46580 |
| K240299 | Zimmer, Inc. |
1800 W. Center Street | Warsaw | IN | 46580 |
| K242543 | Zimmer, Inc. |
1800 W. Center Street | Warsaw | IN | 46580 |
| K141840 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K222566 | Zimmer, Inc. |
1800 W Center Street | Warsaw | IN | 46580 |
| K150090 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K172524 | Zimmer, Inc. |
P.O. Box 708 | Warsaw | IN | 46581-0708 |
| K173417 | Zimmer, Inc. |
P.O. Box 708 | Warsaw | IN | 46581-0708 |
| K121771 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K122745 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
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