Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3660](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3660) → KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented # KWS · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented _Orthopedic · 21 CFR 888.3660 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS ## Overview - **Product Code:** KWS - **Device Name:** Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented - **Regulation:** [21 CFR 888.3660](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3660) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Classification Rationale Class II. The special controls for this device are: ## Special Controls *Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.” ## Recent Cleared Devices (20 of 190) Showing 20 most recent of 190 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254084](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K254084.md) | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | Apr 6, 2026 | SESE | | [K252418](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K252418.md) | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | Nov 6, 2025 | SESE | | [K252416](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K252416.md) | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | Oct 29, 2025 | SESE | | [K241292](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K241292.md) | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | Jan 30, 2025 | SESE | | [K241878](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K241878.md) | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | Dec 6, 2024 | SESE | | [K241609](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K241609.md) | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | Sep 10, 2024 | SESE | | [K230513](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K230513.md) | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | Sep 26, 2023 | SESE | | [K222592](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K222592.md) | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | Jun 23, 2023 | SESE | | [K230572](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K230572.md) | AETOS Shoulder System | Smith & Nephew, Inc. | Jun 7, 2023 | SESE | | [K220847](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K220847.md) | AETOS Shoulder System | Smith & Nephew, Inc. | Jan 3, 2023 | SESE | | [K222317](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K222317.md) | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | Nov 10, 2022 | SESE | | [K213387](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K213387.md) | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | Jul 7, 2022 | SESE | | [K213785](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K213785.md) | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | May 13, 2022 | SESE | | [K213827](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K213827.md) | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | Mar 11, 2022 | SESE | | [K212356](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K212356.md) | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | Mar 4, 2022 | SESE | | [K212435](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K212435.md) | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | Dec 10, 2021 | SESE | | [K210861](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K210861.md) | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | Sep 3, 2021 | SESE | | [K210050](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K210050.md) | Augmented VaultLock Glenoid | Arthrex, Inc. | Jun 7, 2021 | SESE | | [K203315](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K203315.md) | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | Apr 15, 2021 | SESE | | [K203230](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K203230.md) | Global Shoulder and Delta CTA systems | Depuy Lnc. | Apr 2, 2021 | SESE | ## Top Applicants - Arthrex, Inc. — 15 clearances - Tornier — 12 clearances - Smith & Nephew, Inc. — 11 clearances - Tornier, Inc. — 11 clearances - DePuy Orthopaedics, Inc. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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