510(k) · Cleared

Cleared

Integra Total Foot Systems

K123000510(k) TraditionalCleared Dec 21, 201285-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 21, 2012 as substantially equivalent to K100502 (Ascension Orthopedics, Inc., 2010) and 4 other predicates after an 85-day review. Its family tree reaches back 3 generations to 2000. 54 later devices descend from it.

Decided: Dec 21, 2012
Review: 85 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K000684 (2000). 9 ancestors in all. 54 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
1 generation backK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
This deviceK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
Descendant · cites it directly · 23 of its ownK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013 · Recalled
Descendant · 2 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
Descendant · cites it directly · 21 of its ownK163293 Colink™ Plating SystemIn2bones USA, LLC · 2017 · Recalled
Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Descendant · 2 generations on · 16 of its ownK172300 CoLink View Plating SystemIn2bones USA, LLC · 2017

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2013high 8 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 54 · See all

K132594Crosscheck Plating SystemSolana Surgical, LLC · 2013 · cites it directly23descendants
K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 2 generations on22descendants
K163293Colink™ Plating SystemIn2bones USA, LLC · 2017 · cites it directly21descendants
K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
K172300CoLink View Plating SystemIn2bones USA, LLC · 2017 · 2 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−2	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−1	K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010	—
0 (this device)	K123000	Integra Total Foot Systems	Integra LifeSciences Corporation	2012	—
+1	K132594	Crosscheck Plating System	Solana Surgical, LLC	2013	21
+2	K152974	ORTHOLOC® 3Di Foot Plating Reconstruction System	Wrightmedicaltechnologyinc	2015	—
+1	K163293	Colink™ Plating System	In2bones USA, LLC	2017	2
+1	K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	—
+2	K172300	CoLink View Plating System	In2bones USA, LLC	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2006	1	0
2008	1	0
2009	1	0
2010	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2017	3	0
2018	3	0
2019	5	0
2020	8	0
2021	8	0
2022	2	0
2023	7	0
2024	7	0
2025	4	0
2026	5	0

FIG. 1 — Lineage of K123000, 2000–2026Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K100502	Ascension Total Plate System Summary page 2 …mall bones of the feet. Substantial Equivalence Comparison: Components of the INTEGRA' Total Foot System are similar in design and materials to the predicate devices: (K100502, K091614, K094037, K102282, and K063049). Testing and Test Results: The INTEGRA® Total Foot System and Ascension*Total Foot Syst…	Ascension Orthopedics, Inc.	2010	—
*	K091614	Osteomed Foot Plating System Summary page 1 …K100O2 RS;HWCSystem Ascension Orthopedics, Inc. K091614 HRS; HWC Osetomed Foot Plating Osteomed, L.P.…	Osteomed LP	2009	—
*	K094037	TC Plating System Summary page 1 …Inc. K091614 HRS; HWC Osetomed Foot Plating Osteomed, L.P. System K094037 KTT TC Plating System Orthopro, LLC K1222 RSVariAx Locked Plating…	Ortho-Pro, LLC	2010	—
*	K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates Summary page 2 …ubstantial Equivalence Comparison: Components of the INTEGRA' Total Foot System are similar in design and materials to the predicate devices: (K100502, K091614, K094037, K102282, and K063049). Testing and Test Results: The INTEGRA® Total Foot System and Ascension*Total Foot System (K100502) are both syste…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010	—
*	K063049	Synthes (Usa) Modular Mini Fragment LCP System Summary page 2 …uivalence Comparison: Components of the INTEGRA' Total Foot System are similar in design and materials to the predicate devices: (K100502, K091614, K094037, K102282, and K063049). Testing and Test Results: The INTEGRA® Total Foot System and Ascension*Total Foot System (K100502) are both systems comprised…	Synthes (Usa)	2006	4

Also cleared against K100502: 2 other devices →

What descends from it? (54)

See all 54

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132594	Crosscheck Plating System	Solana Surgical, LLC	2013	23
K163293	Colink™ Plating System	In2bones USA, LLC	2017	21
K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	19
K210016	Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…	Integra LifeSciences Corporation	2021	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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
3 of the 9 ancestors have a recall of any class.
Of its descendants, K132594 (Solana Surgical, LLC, 2013) has gone furthest, with 23 descendants of its own.
2 other devices also cite its predicate K100502.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:

- Stabilization and fixation of fresh fractures

- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures

- Revision procedures, joint fusion, and reconstruction of small bones of the feet.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123000 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123000: Integra Total Foot Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123000

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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