# DEN220012: Tornier Pyrocarbon Humeral Head

- Pathway: De Novo (Post-NSE)
- Applicant: Tornier S.A.S.
- Decided: Dec 16, 2022 after 311 days
- Product code: QKW (Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis)
- Device class: 2
- Regulation: 21 CFR 888.3695
- Recalls of this device: none
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by: • Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) • Traumatic arthritis. The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. Note: The coated humeral stem is intended for cemented or cementless use. The non-coated humeral stem is for cemented use only.

Source page: https://510kreport.com/device/DEN220012
Methodology: https://510kreport.com/methodology