510(k) · Cleared

Cleared

Cobra External Fixator

K983881510(k) TraditionalCleared Dec 4, 199832-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

Orthopaedic Innovations, Inc. · HRS Plate, Fixation, Bone

Cleared on Dec 4, 1998 as substantially equivalent to K960014 (Orthopaedic Innovations, Inc., 1996) after a 32-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Dec 4, 1998
Review: 32 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960014 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK960014 Practifix External Fixation SystemOrthopaedic Innovations, Inc. · 1996
This deviceK983881 Cobra External FixatorOrthopaedic Innovations, Inc. · 1998
Descendant · cites it directly · 0 of its ownK012078 RadiofixFixano SA · 2001

Most influential descendants

Showing 1 of 1 · See all

K012078RadiofixFixano SA · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960014	Practifix External Fixation System	Orthopaedic Innovations, Inc.	1996	—
0 (this device)	K983881	Cobra External Fixator	Orthopaedic Innovations, Inc.	1998	—
+1	K012078	Radiofix	Fixano SA	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K983881, 1996–2001Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K960014	Practifix External Fixation System Summary page 1 …tion appliances and accessories (21 CFR 88.3030) Common Name: External Fixation System Trade/Proprietary Name: Cobra External Fixator Orthopaedic Innovations Practifix (K960014), Synthes AO/ASIF and - Howmedica Mini Hoffman External Fixation Systems The device a two-piece hinged external fixator. Set-sc…	Orthopaedic Innovations, Inc.	1996	—
*	—	Synthes AO/ASIF Named without a submission number			—
*	—	Howmedica Mini Hoffman External Fixation Systems Named without a submission number			—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012078	Radiofix	Fixano SA	2001	0

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, K012078 (Fixano SA, 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983881 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983881: Cobra External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983881

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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