De Novo · Granted
GrantedTornier Pyrocarbon Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Granted on Dec 16, 2022 as a new device type through De Novo after a 311-day review.
- Decided
- Dec 16, 2022
- Review
- 311 days
- Class
- Class II
- Product code
- QKW
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QKW devicesQKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QKW
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QKW
Too few QKW 510(k)s in any year since 2007 to give a median.
Recalls per year · QKW
No recall names QKW since 2007.
Adverse event reports per year · QKW
23in 2025
MAUDE reports naming product code QKW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (105 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220012 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN220012: Tornier Pyrocarbon Humeral Head.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN220012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026