FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUMATCH Personalized Solutions
K Number: K193540
·
Decision Jun 16, 2020
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
207
Review Days
179
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRUMATCH Personalized Solutions
- K Number
- K193540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- December 20, 2019
- Decision Date
- June 16, 2020
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by DePuy Orthopaedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252887 | DePuy ATTUNE Knee System | May 22, 2026 | Substantially Equivalent |
| K231503 | CUPTIMIZE Advanced | Aug 22, 2023 | Substantially Equivalent |
| K213839 | DePuy Corail AMT Hip Prosthesis | Jan 6, 2022 | Substantially Equivalent |
| K210167 | DELTA XTEND Reverse Shoulder System | Feb 19, 2021 | Substantially Equivalent |
| K203167 | DePuy Corail AMT Hip Prosthesis | Nov 19, 2020 | Substantially Equivalent |
| K202472 | ACTIS Duofix Hip Prosthesis | Oct 21, 2020 | Substantially Equivalent |
| K201347 | DePuy ATTUNE Total Knee System | Jun 18, 2020 | Substantially Equivalent |
| K193398 | Summit DuoFix HA Coating | Feb 4, 2020 | Substantially Equivalent |
| K192946 | DePuy Corail AMT Hip Prosthesis | Nov 26, 2019 | Substantially Equivalent |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | Nov 26, 2019 | Substantially Equivalent |