510(k) K261734
- Device
- Klassic Infection Spacer System
- Applicant
- Total Joint Orthopedics, Inc.
- 510(k) number
- K261734
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-23
- Date received
- 2026-05-26
- 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
- Georgia Murray
- Address
- 1567 E. Stratford Ave. Salt Lake City UT US 84106 84106
FDA Registration Numbers#
- 1833920
- 9681642
- 3015231789
- 1000517406
- 3002808022
- 3004513872
- 1047843
- 9610726
- 3010041693
- 3010846112
- 1226544
- 3009656988
- 3005874553
- 3004371426
- 3010392243
- 3010576282
- 1221053
- 9681465
- 3009546990
- 3038503932
- 3015167917
- 9680215
- 3026776
- 3008421730
- 1218882
- 1223434
- 3010162973
- 3008285983
- 3020155054
- 1835251
- 9617083
- 3010531069
- 3016096064
- 3015916578
- 3013014058
- 3011461101
- 3014273644
- 3006791286
- 2249615
- 3005852519
- 1643817
- 3007311878
- 3009813841
- 3015398319
- 1646498
- 3010163695
- 3007334927
- 3012329926
- 3011295718
- 3025603301
- 3009555440
- 9611390
- 1834331
- 3005279746
- 3004638532
- 3009293341
- 1828464
- 3027484613
- 3006017180
- 3009882462
- 1219655
- 3009998573
- 3006356043
- 3010537287
- 3004142400
- 1038671
- 3009971621
- 1720929
- 3009241418
- 3017397663
- 3012392319
- 3010009693
- 3007963827
- 3013417938
- 3002806470
- 3010898856
- 3016438694
- 3010097171
- 2032521
Source Documents#
Other 510(k) Records For Product Code JWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |