# K911902: Temperlite (TM) Saw Blade

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Surgical, Inc.
- Decided: Jun 28, 1991 after 63 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 14, 2013 · Class II · Z-1127-2013: Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

Source page: https://510kreport.com/device/K911902
Methodology: https://510kreport.com/methodology