510(k) · Cleared

Cleared

Internal Joint Stabilizer - Elbow

K223318510(k) TraditionalCleared May 10, 2023194-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Skeletal Dynamics, Inc. · OZI Internal Hinged Elbow Fixator

Cleared on May 10, 2023 as substantially equivalent to K153208 (Skeletal Dynamics, LLC, 2015) after a 194-day review. Its family tree reaches back 2 generations to 2000.

Decided: May 10, 2023
Review: 194 days
Class: Class II
Product code: OZI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002923 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002923 Dynamic Joint Distractor II External Fixation SystemHowmedica Osteonics Corp. · 2000
1 generation backK153208 Internal Joint Stabilizer - ElbowSkeletal Dynamics, LLC · 2015
This deviceK223318 Internal Joint Stabilizer - ElbowSkeletal Dynamics, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002923	Dynamic Joint Distractor II External Fixation System	Howmedica Osteonics Corp.	2000	—
−1	K153208	Internal Joint Stabilizer - Elbow	Skeletal Dynamics, LLC	2015	—
0 (this device)	K223318	Internal Joint Stabilizer - Elbow	Skeletal Dynamics, Inc.	2023	—

FIG. 1 — Lineage of K223318, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K153208	Internal Joint Stabilizer - Elbow Summary page 4 …Hinged Elbow Fixator Classification Number: 21 CFR §888.3030 Regulatory Class: Class II Product Code: OZI, LXT, HRS Predicate Devices Internal Joint Stabilizer – Elbow (K153208) Reference Devices Distal Elbow Plating System (K171590) Device Description The Skeletal Dynamic’s Internal Joint Stabilizer Elb…	Skeletal Dynamics, LLC	2015	—
†	K171590	Distal Elbow Plating System	Skeletal Dynamics, LLC	2017	—

Also cleared against K153208: 1 other 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.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K153208.

How does its category compare?

All OZI devices

OZI Internal Hinged Elbow Fixator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · OZI

2in 2023

2007high 2 (2023) · low 0 (2007)2026

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

2007high 8 (2024) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	1
2020	0	—	7
2021	0	—	1
2022	0	—	5
2023	2	—	6
2024	0	—	8
2025	0	—	3
2026	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/K223318 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223318: Internal Joint Stabilizer - Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223318

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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