FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;
K Number: K241000
·
Decision Jul 11, 2024
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
48
Review Days
90
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Basic Information
- Device Name
- ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;
- K Number
- K241000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- April 12, 2024
- Decision Date
- July 11, 2024
- 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 |
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Other Clearances by Depuy Ireland UC
| K Number | Device Name | ||
|---|---|---|---|
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | May 15, 2026 | Substantially Equivalent |
| K253624 | INHANCE Reverse Shoulder System | Mar 11, 2026 | Substantially Equivalent |
| K253551 | VELYS Hip Navigation | Mar 6, 2026 | Substantially Equivalent |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Nov 19, 2025 | Substantially Equivalent |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | May 23, 2025 | Substantially Equivalent |
| K243977 | EMPHASYS Acetabular System | Jan 22, 2025 | Substantially Equivalent |
| K243248 | INHANCE INTACT | Dec 23, 2024 | Substantially Equivalent |
| K242871 | ATTUNE Revision Hinge Knee | Nov 21, 2024 | Substantially Equivalent |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Oct 7, 2024 | Substantially Equivalent |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Jun 18, 2024 | Substantially Equivalent |