Conformity stem, cemented
FDA 510(k) K191056 · United Orthopedic Corporation
510(k) numberK191056
Submission
- Device name
- Conformity stem, cemented
- Applicant
- United Orthopedic Corporation
Hsinchu City, TW - Received
- April 19, 2019
- Decision date
- January 3, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | 09/02/2026SE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type)JWH · Special | 09/25/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | 08/22/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | 07/31/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | 05/01/2025SE |
| K243466 | Conformity Stem Extension Line, #0LZO · Traditional | 01/06/2025SE |
| K243024 | Cellbrick Knee SpacerJWH · Traditional | 12/20/2024SE |
| K242249 | Conformity Stem Extension LineLZO · Special | 08/30/2024SE |
| K221705 | U2 Total Knee System-PF+MBH · Traditional | 02/28/2023SE |
| K221149 | U-Motion II Acetabular System-Extension lineLZO · Traditional | 01/05/2023SE |
Questions and answers
When was Conformity stem, cemented cleared by the FDA?
Conformity stem, cemented (K191056) received a 510(k) decision of Substantially Equivalent on January 3, 2020, 259 days after the submission was received.
What is the product code of K191056?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.