510(k) · Cleared
ClearedComprehensive Humeral Fracture Positioning Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Dec 10, 2021 as substantially equivalent to K193038 (Biomet Manufacturing Corp, 2020) and 1 other predicate after a 128-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Dec 10, 2021
- Review
- 128 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K800494 (1980). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- 1 generation backK193038 Comprehensive Shoulder SystemBiomet Manufacturing Corp · 2020 · Recalled
- This deviceK212435 Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −2 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| −1 | K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 | 1 |
| 0 (this device) | K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) 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 KWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193038 | Comprehensive Shoulder SystemSummary page 4…constrained cemented prosthesis. (21CFR888.3650) Predicate Device(s): K193038 Comprehensive Biomet, INC. Shoulder System… | 2020 |
| * | K033506 | Comprehensive Humeral Fracture Positioning SleeveSummary page 4…K193038 Comprehensive Biomet, INC. Shoulder System K033506 Comprehensive Biomet, INC. Humeral Fracture… | 2004 |
| † | K193546 | Distal Centralizers | 2020 |
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.
What does this lineage say?
- The line of descent spans 41 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 28 ancestors have a recall of any class.
- 3 other devices also cite its predicate K193038.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
INDICATIONS 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional defonnity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, including cuffarthropathy, where other methods oftreatment may not be suitable or may be inadequate. Optional use in revision: in some medical…
Read the full statement (244 words)
INDICATIONS
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional defonnity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, including cuffarthropathy, where other methods oftreatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212435: Comprehensive Humeral Fracture Positioning Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212435
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026