510(k) · Cleared

Recalled · Class II · 2026

FR.O.H. Calcaneus Repair System

K051642510(k) TraditionalCleared Aug 22, 200563-day reviewClass II21 CFR 888.3030Recalls 1

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

I.T.S. Implantat-Technologie-Systeme GmbH · NDF Plate, Fixation, Bone, Non-Spinal, Metallic

Cleared on Aug 22, 2005 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1998. 28 later devices descend from it. It has been recalled once.

Decided: Aug 22, 2005
Review: 63 days
Class: Class II
Product code: NDF
Recalls: 1
Predicates: 3

Its longest line of descent runs back 2 generations to K981372 (1998). 5 ancestors in all, the oldest K903810 (1990). 28 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
1 generation backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
This deviceK051642 FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2005
Descendant · cites it directly · 27 of its ownK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
Descendant · cites it directly · 9 of its ownK063166 I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
Descendant · 2 generations on · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
Descendant · 3 generations on · 4 of its ownK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006high 5 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 28 · See all

K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · cites it directly27descendants
K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · cites it directly9descendants
K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · 2 generations on8descendants
K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981372	Synthes 3.0 MM PC-Fix System	Synthes (Usa)	1998	—
−1	K991407	Synthes Locking Calcaneal Plates	Synthes (Usa)	1999	—
0 (this device)	K051642	FR.O.H. Calcaneus Repair System	I.T.S. Implantat-Technologie-Systeme GmbH	2005	—
+1	K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
+2	K150693	PHIN-FX Cannulated Lag Screw System	Ascent Medical, LLC	2015	—
+1	K063166	I.T.S. Pelvic Reconstruction System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
+2	K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Limited	2011	—
+3	K161904	GEO Bone Screw System	Gramercy Extremity Orthopeidics, LLC	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2015	3	0
2016	1	0
2017	3	0
2020	2	0
2022	4	0
2023	2	0
2024	1	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K051642, 1998–2026Source: 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 NDF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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
*	K991407	Synthes Locking Calcaneal Plates Summary page 1 …fixation fastener (see 21 CFR, Sec. 888.3040) DEVICE PRODUCT CODE: HRS & HWC SUBSTANTIALLY Synthes Locking Calcaneal Plates (1K991407) EQUIVALENT DEVICES DePuy/Ace Calcaneal Peri-articular Plate (K(993465) Ace/DePuy Cannulated Cance…	Synthes (Usa)	1999	—
*	K993465	Depuy Ace Calcaneal Peri-Articular Plate Summary page 1 …E PRODUCT CODE: HRS & HWC SUBSTANTIALLY Synthes Locking Calcaneal Plates (1K991407) EQUIVALENT DEVICES DePuy/Ace Calcaneal Peri-articular Plate (K(993465) Ace/DePuy Cannulated Cancellous Bone Screw (K(903810) DEVICE DESCRIPTION: The 1.T.S. FR.O.H. Cal…	Depuy, Inc.	2000	—
*	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw Summary page 1 …eal Plates (1K991407) EQUIVALENT DEVICES DePuy/Ace Calcaneal Peri-articular Plate (K(993465) Ace/DePuy Cannulated Cancellous Bone Screw (K(903810) DEVICE DESCRIPTION: The 1.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture redu…	Ace Medical Co.	1990	—

Also cleared against K991407: 15 other devices →

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	27
K063166	I.T.S. Pelvic Reconstruction System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	9
K161894	SurgTech Trauma System	Surgtech, Inc.	2017	3
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 23, 2026	Class II	Z-1595-2026	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K060156 (I.T.S. Implantat-Technologie-Systeme GmbH, 2006) has gone furthest, with 27 descendants of its own.
15 other devices also cite its predicate K991407.

How does its category compare?

All NDF devices

NDF Plate, Fixation, Bone, Non-Spinal, Metallic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NDF

FDA has decided no NDF device since 2007.

Median 510(k) review, days · NDF

Too few NDF 510(k)s in any year since 2007 to give a median.

Recalls per year · NDF

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · NDF

1in 2022

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code NDF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	1
2010	—	0	1
2011	—	0	0
2012	—	0	0
2013	—	1	1
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The I.T.S. FR.O.M. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.

Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tongue type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.

This system is not intended for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051642 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051642: FR.O.H. Calcaneus Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051642

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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