510(k) · Cleared
ClearedInternal Joint Stabilizer - Elbow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · OZI Internal Hinged Elbow Fixator
Cleared on Dec 31, 2015 as substantially equivalent to K002923 (Howmedica Osteonics Corp., 2000) after a 56-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 31, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- OZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002923 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002923 Dynamic Joint Distractor II External Fixation SystemHowmedica Osteonics Corp. · 2000
- This deviceK153208 Internal Joint Stabilizer - ElbowSkeletal Dynamics, LLC · 2015
- Descendant · cites it directly · 0 of its ownK231447 Double Internal Joint Stabilizer- ElbowSkeletal Dynamics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK223318 Internal Joint Stabilizer - ElbowSkeletal Dynamics, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002923 | Dynamic Joint Distractor II External Fixation System | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K153208 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, LLC | 2015 | — |
| +1 | K231447 | Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc. | 2023 | — |
| +1 | K223318 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 OZI? 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 OZI device
- #1 K231447 Double Internal Joint Stabilizer- Elbowscore 6.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K002923 | Dynamic Joint Distractor II External Fixation SystemSummary page 4…Metal Composite Classification: 21 C.F.R. § 888.3030 Product Code: OZI; LXT Class: II Predicate Device: Howmedica (now Stryker) Dynamic Joint Distractor II (K002923) Device Description – Technological Characteristics: The Skeletal Dynamics Internal Joint Stabilizer – Elbow is an internal elb… | 2000 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K231447 (Skeletal Dynamics, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OZI devicesOZI Internal Hinged Elbow Fixator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OZI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OZI
Too few OZI 510(k)s in any year since 2007 to give a median.
Recalls per year · OZI
No recall names OZI since 2007.
Adverse event reports per year · OZI
3in 2025
MAUDE reports naming product code OZI, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Internal Joint Stabilizer – Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153208 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153208: Internal Joint Stabilizer - Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153208
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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