Most Options System
FDA 510(k) K013031 · Sulzer Orthopedics, Inc.
510(k) numberK013031
Submission
- Device name
- Most Options System
- Applicant
- Sulzer Orthopedics, Inc.
Austin, TX, US - Received
- September 10, 2001
- Decision date
- December 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3510
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 12/15/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | United Orthopedic Corporation | 08/22/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/25/2025SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | Depuy Ireland UC | 11/21/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | Microport Orthopedics, Inc. | 04/01/2024SE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional | Depuy Ireland UC | 03/21/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | Microport Orthopedics, Inc. | 09/27/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | Stryker | 05/19/2023SE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/21/2023SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K022985 | Ascendent Acetabular SystemLZO · Traditional | 12/05/2002SE |
| K021578 | Natural-Knee II System Cocr Tibial BaseplateJWH · Traditional | 08/09/2002SE |
| K020713 | MS-30 Lateral Femoral StemLZO · Traditional | 05/14/2002SE |
| K013935 | Allofit Acetabular System 32MM Alpha Durasul InsertsLZO · Special | 12/13/2001SE |
| K012739 | Converge Acetabular SystemLPH · Traditional | 11/14/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | 10/18/2001SE |
| K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeHSX · Traditional | 09/19/2001SE |
| K010839 | CLS Varus Stem/Cls 135 StemLZO · Special | 04/18/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | 03/07/2001SE |
| K003801 | Anatomical Press-Fit Humeral StemKWS · Traditional | 02/28/2001SE |
Questions and answers
When was Most Options System cleared by the FDA?
Most Options System (K013031) received a 510(k) decision of Substantially Equivalent on December 7, 2001, 88 days after the submission was received.
What is the product code of K013031?
The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.