510(k) K981560
- Device
- IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
- Applicant
- IMPLEX CORP.
- 510(k) number
- K981560
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-08
- Date received
- 1998-05-01
- 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
Applicant Contact#
- Contact
- JOHN A SCHALAGO
- Address
- 80 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3016851379
- 3013055499
- 3021008900
- 3010576282
- 3006563559
- 3014763043
- 3000264985
- 3010400367
- 3014252644
- 3006487372
- 3005751028
- 3021566676
- 1832228
- 2249615
- 3010120104
- 3011724582
- 3013014058
- 9617083
- 3009971621
- 1643817
- 3008544874
- 1529009
- 3010392243
- 3012130008
- 3002806470
- 8043792
- 3005061536
- 1834331
- 9613350
- 3009973505
- 1818910
- 3014302784
- 3009555440
- 3009293341
- 2183744
- 3010331645
- 1047843
- 3006128100
- 1531174
- 3006015326
- 9616680
- 3007200272
- 3005180920
- 9613369
- 3010123256
- 3004153896
- 3006849754
- 1645151
- 3008110533
- 3004976965
- 3007516837
- 3010462278
- 3007923096
- 3004196040
- 3009732568
- 3009848551
- 3007311878
- 3005852519
- 3003477135
- 3030446955
- 3017397663
- 1649518
- 1530390
- 1644408
- 1219655
- 3018052045
- 3012329926
- 3042172882
- 3005144609
- 3012491394
- 3010097171
- 3004142400
- 3004513872
- 3010537287
- 3002807112
- 1822565
- 3009887475
- 3009923578
- 3014315560
- 9614841
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262057 | GMK Extension | Medacta International SA | 2026-09-15 |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026-09-11 |
| K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-09-10 |
| K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | 2026-09-08 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | 2026-09-04 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026-09-01 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | 2026-07-31 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 |
| 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 |
Legacy Summary#
summary
FDA Review#
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