510(k) K980925
- Device
- DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K980925
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-16
- Date received
- 1998-03-11
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- MARGARET F CROWE
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers
- 1450662
- 3008985661
- 3033796901
- 3014252644
- 2183744
- 3010537287
- 3023852420
- 1834331
- 3003541440
- 3013194153
- 9681258
- 1827096
- 3002807112
- 2032521
- 1643264
- 3016090213
- 3026771806
- 1219655
- 3009293341
- 1319660
- 3009475821
- 1064858
- 3002807314
- 3010846112
- 2249697
- 3019767615
- 3010331645
- 3006128100
- 3002808022
- 1000550978
- 3020155054
- 3005751028
- 3002807295
- 1061927
- 3009887475
- 9616680
- 2025182
- 1221053
- 3010047454
- 3009555447
- 3005279746
- 3009973505
- 9614841
- 3020745236
- 1530390
- 3006017180
- 3008021110
- 3005852519
- 3009813841
- 3002806470
- 3007516837
- 1833986
- 3005718816
- 3014273644
- 3035366890
- 3009848551
- 1722511
- 3012725451
- 1818910
- 3011274144
- 3016096064
- 3008658204
- 8043792
- 3008395353
- 1219602
- 3010576282
- 1836357
- 3013843055
- 3013186738
- 3014302784
- 3010898856
- 1423662
- 3027484613
- 2242737
- 3021566676
- 3013176080
- 3002807315
- 3017410889
- 3010386387
Source Documents
Other 510(k) Records For Product Code JWH
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|---|---|---|---|
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2025-11-19 |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | 2025-09-25 |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025-07-08 |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. | 2025-07-02 |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 |
Legacy Summary
summary
FDA Review
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