# K961260: Kirschner Sholders with Titanium Plasma Spray

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 2, 1997 after 365 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873073 (1987). 4 ancestors in all.
176 later devices descend from it; 3 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873073: Kirschner Neer-Iii Proximal Humerus, Kirschner Medical Corp. (1987) Summary page 2.
- K874643: Kirschner Neer-Iii Modular Proximal Humerus, Kirschner Medical Corp. (1988) Summary page 2.
- K940537: Kirschner (R) Modular II-C (TM) Total Shoulder System, Kirschner Medical Corp. (1995) Summary page 2.
- K873104: Neer-Iii Glenoid Resurfacing Prosthesis, Kirschner Medical Corp. (1987) Summary page 2.

## Most influential descendants
- K023063: Comprehensive Humeral Fracture System (2002), 146 descendants of its own
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 descendants of its own
- 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

## Indications for use
1) Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenchumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united or mal-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.

Source page: https://510kreport.com/device/K961260
Methodology: https://510kreport.com/methodology