Anatomic Proportional Shoulder APS (Hemi-Shoulder) System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935593 ↗

FDA Product Code

HSD

Device Class

Class II

Regulation

21 CFR Part 888.3690

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• EZ-FIX Small Cannulated Screw System

  Class II

  FDA 510(k) K962987 Active Cleared 4 Nov 1996

• Shoulder-Holder

  Not classified

  FDA 510(k) K851206 Active Cleared 25 Apr 1985

• Universal Power Flex

  Class I

  FDA 510(k) K851177 Active Cleared 28 Jun 1985

• Biodynamics Femoral Canal Brush #1201

  Class I

  FDA 510(k) K870349 Active Cleared 13 Feb 1987

• Universal Bone Cement Kit

  Class II

  FDA 510(k) K931540 Active Cleared 27 Jan 1994

• Osteomill Bone Grinder

  Class I

  FDA 510(k) K861164 Active Cleared 2 May 1986

See all devices from Biodynamic Technologies, Inc. →

• What is the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System used for?

  The Anatomic Proportional Shoulder APS (Hemi-Shoulder) System is designed for hemi-shoulder arthroplasty, specifically replacing the humeral head in partial shoulder joint replacement procedures. It is intended to restore function and stability to the shoulder joint following trauma, degenerative disease, or other conditions where partial joint replacement is required. The system is not intended for total shoulder replacement but focuses on restoring mobility and reducing pain in partial joint dysfunction.

• Is the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System single-use or reusable?

  The Anatomic Proportional Shoulder APS (Hemi-Shoulder) System is supplied as a sterile, single-use orthopedic implant. This ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in surgical settings. Reuse is not recommended due to the risk of compromising sterility and device integrity.

• How should the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System be stored?

  The system must be stored according to medical device sterilization standards to preserve its integrity and safety. Proper storage conditions include maintaining the sterile packaging, protecting it from physical damage, and adhering to manufacturer guidelines for shelf life and environmental controls (e.g., temperature, humidity). Always follow the storage instructions provided by Biodynamic Technologies to ensure the device remains viable for surgical use.

• Can the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System be used with MRI?

  No, the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System is not MRI-safe. Metallic implants can interfere with MRI imaging and may pose risks such as heating or artifacts, which could compromise diagnostic accuracy or patient safety. Clinicians should avoid MRI procedures involving this device and use alternative imaging modalities when necessary.

• What regulatory approval does the Anatomic Proportional Shoulder APS (Hemi-Shoulder) System hold?

  The Anatomic Proportional Shoulder APS (Hemi-Shoulder) System holds FDA 510(k) clearance under the reference number K935593. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for shoulder prostheses under product code HSD. The system is also subject to Class II special controls for orthopedic devices.