510(k) K101356
- Device
- SPACER-K, SPACER-G, SPACER-S
- Applicant
- TECRES SPA
- 510(k) number
- K101356
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-20
- Date received
- 2010-05-14
- 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
- CHRISTINE BRAUER
- Address
- 7 Trl. House Ct. Rockville MD US 20850 20850
FDA Registration Numbers#
- 3009888740
- 3000236920
- 3010057495
- 1721676
- 3004635447
- 3013302242
- 8044172
- 9681465
- 1833986
- 3010041693
- 3034676720
- 3006085220
- 1834331
- 3010178296
- 8010379
- 1645151
- 3009973336
- 3012329926
- 3014302784
- 3016438761
- 3025603301
- 3005913274
- 3008262872
- 3021566676
- 3006395932
- 9613369
- 1526534
- 1649518
- 3014763043
- 3002808022
- 9610921
- 3008572101
- 3013055499
- 3002807314
- 3013186738
- 3006406161
- 3038503932
- 2249697
- 3011277306
- 2134285
- 1221763
- 3008556682
- 9613350
- 1221053
- 2246552
- 3008812251
- 3015516266
- 2245304
- 2648920
- 3008110533
- 2133928
- 3010314800
- 3035366890
- 3011683674
- 3004153896
- 1424263
- 3023852420
- 9616671
- 1720929
- 3006849754
- 2244478
- 1643817
- 3004142400
- 9614209
- 3015542154
- 3000196378
- 3004126422
- 3004748528
- 3020155054
- 3013176080
- 3012130008
- 3006356043
- 3002807295
- 1219655
- 1020279
- 3009760038
- 3007366790
- 1529009
- 3012392319
- 3030412764
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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