510(k) K240043
- Device
- EVOLUTION® Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS
- Applicant
- Microport Orthopedics, Inc.
- 510(k) number
- K240043
- Product code
- KRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-01
- Date received
- 2024-01-05
- Regulation
- 888.3510
- Classification name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, 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
- Thaiz Cruz Vasquez
- Address
- 5677 Airline Rd. Arlington TN US 38002 38002
FDA Registration Numbers#
- 1000550978
- 9616680
- 1225675
- 1218882
- 2528981
- 3022142628
- 9610612
- 2244478
- 1423662
- 3021008900
- 9610622
- 3033509898
- 3008110533
- 3009813841
- 3009760038
- 3010041993
- 3007189546
- 3005562917
- 2648920
- 1047843
- 3002907620
- 3009973505
- 3012755988
- 3011061242
- 3004371426
- 2249697
- 3008868758
- 3006395932
- 2245304
- 3001284227
- 3010097171
- 3008556682
- 9616671
- 8043792
- 3014680795
- 1057425
- 1818910
- 1836357
- 3000264985
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 9616944
- 3005180920
- 3005551626
- 3029890418
- 1020279
- 3011015572
- 1825034
- 3003639920
- 2183946
- 3007539489
- 1833986
- 3013055499
- 3009923578
- 1822565
- 3016438694
- 3010536692
- 3009848551
- 1526534
- 3011187779
- 3025603301
- 1219655
- 3002807315
- 3009732568
- 3015207155
- 3010173425
- 3005751028
- 3010288357
- 3004748528
- 3020703621
- 2134285
- 1828464
- 3009882462
- 2249615
- 3004513872
- 1834379
- 3003387384
Source Documents#
Other 510(k) Records For Product Code KRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-12-15 |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025-08-22 |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 |
| K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | 2024-11-21 |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | 2024-03-21 |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | 2023-09-27 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | 2023-05-19 |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-04-21 |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-20 |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022-05-03 |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | 2021-07-28 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | 2021-06-30 |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021-03-02 |
| K192798 | Zimmer Segmental System | Zimmer, Inc. | 2020-12-10 |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019-10-25 |