510(k) K001307
- Device
- CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
- Applicant
- IMPLEX CORP.
- 510(k) number
- K001307
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-23
- Date received
- 2000-04-24
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN SCHALAGO
- Address
- 80 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3007353762
- 3015978338
- 3008824097
- 2249615
- 3012319330
- 1644408
- 3011061242
- 3005279746
- 3009555440
- 3002806470
- 3025603301
- 3004748528
- 3034676720
- 2032521
- 3005874553
- 3006128100
- 3009590742
- 3008395353
- 3009998573
- 1220246
- 1720929
- 9616680
- 3010173425
- 3011461101
- 1835251
- 3013843055
- 3005718816
- 3019006180
- 1835444
- 1724955
- 3010178296
- 1835572
- 1450662
- 1530390
- 3010047454
- 3033796901
- 3003541440
- 3009106092
- 8043792
- 3010314800
- 3015806723
- 3008868758
- 3006356043
- 3009871135
- 9613369
- 3016096064
- 2242737
- 1319660
- 3009888740
- 3010132111
- 3010163695
- 3010856250
- 1000200989
- 3008812251
- 3042172882
- 3010898856
- 3016438694
- 3016090213
- 3008285983
- 1223434
- 3007200272
- 3020155054
- 3007366790
- 1834331
- 3004196040
- 3002807112
- 3004450489
- 3010846112
- 3014252644
- 3009732568
- 3010288357
- 3015167917
- 3013417938
- 3018052045
- 3004976965
- 3009475821
- 3015916578
- 3004153240
- 1038671
- 3008985661
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263065 | MicroPort Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-10-29 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases