FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Conformity Stem
K Number: K183312
·
Decision Aug 8, 2019
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
40
Review Days
252
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
- Conformity Stem
- K Number
- K183312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corporation
- Date Received
- November 29, 2018
- Decision Date
- August 8, 2019
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.
Z1 Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Avenir® Müller Stem; Avenir Complete Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
implantcast Packaging System Update
FDA 510(k)
FDA Class 2
·Orthopedic
implaFit® short stems
FDA 510(k)
FDA Class 2
·Orthopedic
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Coated hip implants
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by United Orthopedic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | Sep 25, 2025 | Substantially Equivalent |
| K252303 | Stem Extension Line (USTAR II System) | Aug 22, 2025 | Substantially Equivalent |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | Jul 31, 2025 | Substantially Equivalent |
| K242315 | Resolve Modular Revision Hip Stem | May 1, 2025 | Substantially Equivalent |
| K243466 | Conformity Stem Extension Line, #0 | Jan 6, 2025 | Substantially Equivalent |
| K243024 | Cellbrick Knee Spacer | Dec 20, 2024 | Substantially Equivalent |
| K242249 | Conformity Stem Extension Line | Aug 30, 2024 | Substantially Equivalent |
| K221705 | U2 Total Knee System-PF+ | Feb 28, 2023 | Substantially Equivalent |
| K221149 | U-Motion II Acetabular System-Extension line | Jan 5, 2023 | Substantially Equivalent |
| K221675 | United U2 femoral head, 22mm delta ceramic head | Nov 4, 2022 | Substantially Equivalent |