# K060692: Comprehensive Primary Shoulder Stems

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: May 30, 2006 after 76 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800494 (1980). 24 ancestors in all.
138 later devices descend from it; 15 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K023063: Comprehensive Humeral Fracture System, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K961260: Kirschner Sholders with Titanium Plasma Spray, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K120794: Ascend Shoulder System (2012), 98 descendants of its own
- K121493: Ascend Shoulder System (2012), 97 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own

## Recalls of this device
- Feb 17, 2020 · Class II · Z-1543-2020: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
- Oct 10, 2018 · Class II · Z-0591-2019: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini H
- Dec 8, 2017 · Class II · Z-0980-2018: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. T
- Dec 8, 2017 · Class II · Z-0979-2018: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. T
- Jun 5, 2017 · Class II · Z-0299-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Apr 16, 2015 · Class III · Z-1755-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

## Indications for use
The Comprehensive® Primary Shoulder Stems are intended for heml or total shoulder replacement: 1) Non-Inflammatory degenerative joint disease, including osteoarthritls and avascular necrosis. 2) Rheumatoid arthritis. 3) Revision where other devices or treatments have failed. 4) Correction of functional deformity. 5) Fractures of the proximal humerus where other methods of treatment are deemed inadequate. 6) Difficult clinical management problems, Including cuff tear aithropathy, where other methods of treatment may not be suitable or may be Inadequate. Humeral/glenold components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenold components offer optional screw fixation.) The Comprehensive® Primary Shoulder Stems are intended for use only with the Bio-Modular® humeral heads and glenoid components and the Versa-Dial TM humeral head components. The devices are single-use Implants.

Source page: https://510kreport.com/device/K060692
Methodology: https://510kreport.com/methodology