510(k) · Cleared

Cleared

Integra Total Wrist Fusion System

K093163510(k) TraditionalCleared Dec 15, 200970-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

Integra LifeSciences Corporation · HRS Plate, Fixation, Bone

Cleared on Dec 15, 2009 as substantially equivalent to K000558 (Synthes (Usa), 2000) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1992.

Decided: Dec 15, 2009
Review: 70 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K915818 (1992). 6 ancestors in all, the oldest K800806 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
2 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
1 generation backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
This deviceK093163 Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K915818	Synthes (R) Titanium Small Reconstruction Plate	Synthes (Usa)	1992	2
−2	K990094	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	1999	—
−1	K991873	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	1999	—
0 (this device)	K093163	Integra Total Wrist Fusion System	Integra LifeSciences Corporation	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
2000	1	0
2004	1	0

FIG. 1 — Lineage of K093163, 1992–2009Source: 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
*	K000558	Synthes (Usa) Wrist Fusion Plates (WFP) Summary page 2 …a-LS.corr Substantial Equivalence: The INTEGRAm Total Wrist Fusion System is substantially equivalent to the commercially available devices, Synthes® Wrist Fusion Set, K000558, Synthes® Locking Compression Plate (LCP) Wrist Fusion Set, K042355, and KMI Wrist Fusion System, K991873, which have all been re…	Synthes (Usa)	2000	—
*	K042355	Synthes (Usa) LCP Wrist Fusion Plates Summary page 2 …System is substantially equivalent to the commercially available devices, Synthes® Wrist Fusion Set, K000558, Synthes® Locking Compression Plate (LCP) Wrist Fusion Set, K042355, and KMI Wrist Fusion System, K991873, which have all been recommended for classification as Class II by the Orthopedic Panel of…	Synthes (Usa)	2004	—
*	K991873	Kmi Wrist Fusion System Summary page 2 …the commercially available devices, Synthes® Wrist Fusion Set, K000558, Synthes® Locking Compression Plate (LCP) Wrist Fusion Set, K042355, and KMI Wrist Fusion System, K991873, which have all been recommended for classification as Class II by the Orthopedic Panel of the Food and Drug Administration. In a…	Kinetikos Medical, Inc.	1999	—
†	K063820	Lisfranc Plate	New Deal, S.A.	2007	—

Also cleared against K000558: 7 other devices →

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 17 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
1 of the 6 ancestors has a recall of any class.
7 other devices also cite its predicate K000558.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 INTEGRA Total Wrist Fusion System is indicated for use in patients with:

* Posttraumatic arthritis of the joints of the wrist

* Rheumatoid wrist deformities requiring restoration

* Complex carpal instability

* Post-septic arthritis of the wrist

* Severe unremitting wrist pain related to motion

* Brachial plexus nerve palsies

* Tumor resection

* Spastic deformation

* Pain and/or loss of function due to osteoarthritis

* Revision of failed partial wrist fusions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093163: Integra Total Wrist Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093163

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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