510(k) · Cleared
ClearedInterlok Bio-Modular Humeral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Sep 5, 2003 as substantially equivalent to K992119 (Biomet, Inc., 1999) after a 22-day review. Its family tree reaches back 1 generation to 1999. 123 later devices descend from it.
- Decided
- Sep 5, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992119 (1999). 123 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992119 Bio-Modular Shoulder SystemBiomet, Inc. · 1999 · Recalled
- This deviceK032507 Interlok Bio-Modular Humeral StemsBiomet, Inc. · 2003
- Descendant · cites it directly · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- Descendant · 2 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · cites it directly120descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 2 generations on110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
- K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on105descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992119 | Bio-Modular Shoulder System | Biomet, Inc. | 1999 | 1 |
| 0 (this device) | K032507 | Interlok Bio-Modular Humeral Stems | Biomet, Inc. | 2003 | — |
| +1 | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| +2 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…ection 888.3690) Legally Marketed Devices Ta Whlch Substantial Equivalence Is Claimed: Devices are a modification of The Bio-Modular@Shoulder System cleared in 51O(k) K992119. DevIce Description: 0 Manufactured from Ti-6Al-4V Bi-planer tapered stem 30 grit blasted Interloko surface finish L… | 1999 |
What descends from it? (123)
See all 1232 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
Difficult clinical management problems, including cuff arthropathy, where other methods may not be suitable or may be inadequate
Non-coated (Interlok®) devices are indicated for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032507: Interlok Bio-Modular Humeral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032507
Report an extraction error
Are you the manufacturer?
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