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#
- 3010314800
- 1836357
- 1828464
- 1526534
- 1818910
- 3002807314
- 1424263
- 1720929
- 3004748528
- 9681465
- 9614209
- 3004371426
- 3009973336
- 3021566676
- 9616671
- 1833986
- 3005551626
- 2249615
- 2648920
- 3004635447
- 9616680
- 3033509898
- 1822565
- 1825034
- 3020155054
- 3010178296
- 9610726
- 3007740680
- 3004513872
- 3009732568
- 1038671
- 3007923096
- 3035366890
- 1220477
- 3008556682
- 3016438761
- 3006406161
- 3015516266
- 2245304
- 3005913274
- 3007353762
- 1649518
- 3015542154
- 3008812251
- 3012392319
- 3021008900
- 3038503932
- 1644408
- 9613369
- 3005323511
- 1450662
- 3003387384
- 3006801265
- 3011295718
- 1828288
- 9613350
- 3010537287
- 3006395932
- 1835251
- 3002907620
- 3002807315
- 3007366790
- 3006017180
- 3004142400
- 3010097171
- 3023852420
- 3002807310
- 1722511
- 3008744062
- 1219655
- 3004153896
- 3010173425
- 3013014058
- 3014302784
- 3010536692
- 2134285
- 3002807295
- 3013186738
- 3007913880
- 3008262872
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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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