510(k) K260063
- Device
- GSPE Spacer
- Applicant
- The General Hospital Corporation, d/b/a Massachusetts
- 510(k) number
- K260063
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-11
- Date received
- 2026-01-08
- 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
- N
Applicant Contact#
- Contact
- Orhun Muratoglu
- Address
- General Hospital Mgb Innovation Suite 999, 399 Revolution Dr. Somerville MA US 02145 02145
FDA Registration Numbers#
- 3012491394
- 2183946
- 3009871135
- 3010392243
- 3009760038
- 3009475821
- 1833506
- 2242737
- 1526534
- 3009971621
- 3010400367
- 3018052045
- 3008868758
- 3005581234
- 3003541440
- 3005718816
- 3010120104
- 3007200272
- 3011724582
- 3014273644
- 1220477
- 1835444
- 3010039400
- 3010386387
- 3014644608
- 3008285983
- 3007334927
- 1828288
- 9681258
- 3008658204
- 1450662
- 3009813841
- 3010856250
- 2030624
- 3016470314
- 3003639920
- 3006015326
- 9610612
- 3010531069
- 3034676720
- 3019767615
- 3010047454
- 3004371426
- 3010898856
- 3004976965
- 3005144609
- 1531174
- 3012392319
- 3007366790
- 9617083
- 3014763043
- 3000236920
- 1061927
- 3015516266
- 1424263
- 3016851379
- 3010288357
- 1834331
- 1720929
- 1054811
- 3015207155
- 2134285
- 3014315560
- 3019006180
- 3007516837
- 3002807314
- 3004748528
- 3027484613
- 3014833750
- 3012329926
- 3004153896
- 2249697
- 9614841
- 3006694268
- 3015231789
- 3021566676
- 1218882
- 1000200989
- 3009555447
- 1833986
Source Documents#
Other 510(k) Records For Product Code JWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | 2025-09-25 |