# K954559: Howmedicca Modular Proximal Humerus Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 12, 1996 after 284 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
No predicates in its family tree.
110 later devices descend from it; 5 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Proximal Humerus Replacement (Howmedica): named in the summary without a submission number
- (no number) Neer II Proximal Humerus (Howmedica): named in the summary without a submission number
- (no number) Neer III Modular Proximal Humerus (Kirschner): named in the summary without a submission number
- (no number) Select Shoulder (Intermedics): named in the summary without a submission number
- (no number) NJ Shoulder (DePuy): named in the summary without a submission number
- (no number) PMI Proximal Humeral Segmental System (Biomet): named in the summary without a submission number
- (no number) Precision Osteolock™ Femoral Stems (Howmedica): named in the summary without a submission number
- (no number) P.C.A.® E-Series Hip (Howmedica): named in the summary without a submission number

## Most influential descendants
- K983404: Type 3 Femoral Components (1998), 102 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K022549: Restoration Modular System (2002), 54 descendants of its own
- K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own
- K120578: Accolade II Hip Stem (2012), 46 descendants of its own

## Indications for use
These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.

Source page: https://510kreport.com/device/K954559
Methodology: https://510kreport.com/methodology