Exeter® X3® RimFit® Cup
FDA 510(k) K213701 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) numberK213701
Submission
- Device name
- Exeter® X3® RimFit® Cup
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Mahwah, NJ, US - Received
- November 24, 2021
- Decision date
- February 1, 2022
- 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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| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
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| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | 08/06/2026SE |
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| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | 10/24/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | 07/25/2025SE |
| K250989 | Stryker and Serf hip devicesLPH · Traditional | 07/25/2025SE |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…JWH · Traditional | 02/06/2025SE |
| K243784 | Stryker Orthopaedics Hip Devices Labeling UpdateLPH · Traditional | 02/06/2025SE |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…JWH · Traditional | 12/04/2024SE |
Questions and answers
When was Exeter® X3® RimFit® Cup cleared by the FDA?
Exeter® X3® RimFit® Cup (K213701) received a 510(k) decision of Substantially Equivalent on February 1, 2022, 69 days after the submission was received.
What is the product code of K213701?
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.