510(k) · Cleared

Recalled · Class II · 2026

I.T.S. Extremity Fixation Systems

K131722510(k) TraditionalCleared Aug 7, 201356-day reviewClass II21 CFR 888.3030Recalls 2

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

I.T.S. GmbH · HRS Plate, Fixation, Bone

Cleared on Aug 7, 2013 as substantially equivalent to K111678 (Ortho Solutions Limited, 2012) and 14 other predicates after a 56-day review. Its family tree reaches back 10 generations to 1996. 24 later devices descend from it. It has been recalled 2 times.

Decided: Aug 7, 2013
Review: 56 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 15

Its longest line of descent runs back 10 generations to K962616 (1996). 151 ancestors in all, the oldest K792022 (1979). 24 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
6 generations between
3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
This deviceK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013
Descendant · cites it directly · 11 of its ownK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
Descendant · 2 generations on · 7 of its ownK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
Descendant · 3 generations on · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
Descendant · 4 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
Descendant · cites it directly · 3 of its ownK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled

Show all 10 generations

Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
This deviceK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2014high 4 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 24 · See all

K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017 · cites it directly11descendants
K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021 · 2 generations on7descendants
K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 3 generations on4descendants
K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 4 generations on3descendants
K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−10	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−9	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−8	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−7	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−6	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−5	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−4	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−3	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
−2	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
−1	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
0 (this device)	K131722	I.T.S. Extremity Fixation Systems	I.T.S. GmbH	2013	—
+1	K172617	Treace Medical Concepts (TMC) Compression Screw System	Treace Medical Concepts, Inc.	2017	—
+2	K213036	Treace Medical Concepts (TMC) Screw Fixation System	Treace Medical Concepts, Inc.	2021	—
+3	K240173	Treace Medical Systems (TMC) Plating System	Treace Medical Concepts, Inc.	2024	1
+4	K242415	TMC Compression Implant System	Treace Medical Concepts	2024	—
+1	K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	I.T.S. GmbH	2022	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	1	0
1981	1	0
1989	3	0
1990	2	0
1991	1	0
1992	5	0
1993	3	0
1994	6	0
1995	6	0
1996	14	0
1997	3	0
1998	3	0
1999	8	0
2000	10	0
2001	11	0
2002	11	0
2003	5	0
2004	5	0
2005	11	0
2006	10	0
2007	7	0
2008	4	0
2009	5	0
2010	3	0
2011	1	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	3	0
2017	2	0
2019	1	0
2021	1	0
2022	3	0
2023	3	0
2024	4	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K131722, 1996–2026Source: 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? (15)

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
*	K111678	Ortho Solutions Extremity Fixation Implants for Osteosysnthesis Summary page 1 …DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: IJWC SUBSTANTIALLY Ortho Solutions - Extremity Fixation Implants (K1 11678) EQUIVALENT DEVICES Stryker- Foot Plating Systems (K060613, K063875) Memometal - Anchorage Bone…	Ortho Solutions Limited	2012	1
*	K060613	Variax Locking Plate System Summary page 1 …CODE: IJWC SUBSTANTIALLY Ortho Solutions - Extremity Fixation Implants (K1 11678) EQUIVALENT DEVICES Stryker- Foot Plating Systems (K060613, K063875) Memometal - Anchorage Bone Plate System (K083447) Smith & Nephew -…	Howmedica Osteonics Corp.	2006	—
*	K063875	Stryker Foot Plating System Summary page 1 …IJWC SUBSTANTIALLY Ortho Solutions - Extremity Fixation Implants (K1 11678) EQUIVALENT DEVICES Stryker- Foot Plating Systems (K060613, K063875) Memometal - Anchorage Bone Plate System (K083447) Smith & Nephew - VLP Varia…	Howmedica Osteonics Corp.	2007	—
*	K083447	Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 Summary page 1 …ixation Implants (K1 11678) EQUIVALENT DEVICES Stryker- Foot Plating Systems (K060613, K063875) Memometal - Anchorage Bone Plate System (K083447) Smith & Nephew - VLP Variable-Angle System (K(090675) Synthes - 2.4/2.7mm Va…	Memometal Technologies	2009	—
*	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories Summary page 1 …ms (K060613, K063875) Memometal - Anchorage Bone Plate System (K083447) Smith & Nephew - VLP Variable-Angle System (K(090675) Synthes - 2.4/2.7mm Variable Angle (VA)-LCP Forefoot/ Midfoot System (K10077…	Smith & Nephew, Inc.	2009	—
*	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System Summary page 1 …& Nephew - VLP Variable-Angle System (K(090675) Synthes - 2.4/2.7mm Variable Angle (VA)-LCP Forefoot/ Midfoot System (K100776) Vilex - Cannulated Dual Thread Screws (1(014154) Memometal - FIXOS Compressi…	Synthes (Usa)	2010	—
*	K014154	Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone… Summary page 1 …nthes - 2.4/2.7mm Variable Angle (VA)-LCP Forefoot/ Midfoot System (K100776) Vilex - Cannulated Dual Thread Screws (1(014154) Memometal - FIXOS Compression Screws (K(070039) Merete Medical - Cannulated…	Vilex, Inc.	2002	—
*	K070039	Memometal Fixos Screws Summary page 1 …Midfoot System (K100776) Vilex - Cannulated Dual Thread Screws (1(014154) Memometal - FIXOS Compression Screws (K(070039) Merete Medical - Cannulated 1-ICS Compression Screws (K091798)…	Memometal Technologies	2007	—
*	K091798	Merete Compression Screws Summary page 1 …Memometal - FIXOS Compression Screws (K(070039) Merete Medical - Cannulated 1-ICS Compression Screws (K091798) Integra - QWIX Fixation Screws (K(071639) Arthrex - Low Profile Plate and Sc…	Merete Medical GmbH	2009	—
*	K071639	Qwix Positioning Screw Summary page 1 …Merete Medical - Cannulated 1-ICS Compression Screws (K091798) Integra - QWIX Fixation Screws (K(071639) Arthrex - Low Profile Plate and Screw System (K(052614) SBI - ForeFIX 11 (K0…	Newdeal Sas	2007	1
*	K052614	Low Profile Plate and Screw System Summary page 1 …(K091798) Integra - QWIX Fixation Screws (K(071639) Arthrex - Low Profile Plate and Screw System (K(052614) SBI - ForeFIX 11 (K071479) Biomet - BioDrive Micro NailI Plate (K092670)…	Arthrex, Inc.	2005	—
*	K071479	Sbi Stafix Summary page 1 …Integra - QWIX Fixation Screws (K(071639) Arthrex - Low Profile Plate and Screw System (K(052614) SBI - ForeFIX 11 (K071479) Biomet - BioDrive Micro NailI Plate (K092670) Memometal - FIXOS Twist-Off Sc…	Small Bone Innovations, Inc.	2007	—
*	K092670	Biodrive Micro Screw System Summary page 1 …threx - Low Profile Plate and Screw System (K(052614) SBI - ForeFIX 11 (K071479) Biomet - BioDrive Micro NailI Plate (K092670) Memometal - FIXOS Twist-Off Screw (K(070039) Wright Medical - Charlotte Snap…	Ebi,Llc D/B/A Biomet Trauma	2009	—
*	K050819	Charlotte Snap-Off Screw Summary page 1 …icro NailI Plate (K092670) Memometal - FIXOS Twist-Off Screw (K(070039) Wright Medical - Charlotte Snap-Off Screws (K(050819, K043583) L.T.S. Extremity Fixation Systems Page 1 of 4 Section…	Wrightmedicaltechnologyinc	2005	—
*	K043583	Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 Summary page 1 …Memometal - FIXOS Twist-Off Screw (K(070039) Wright Medical - Charlotte Snap-Off Screws (K(050819, K043583) L.T.S. Extremity Fixation Systems Page 1 of 4 Section XII I.T'.S.GmblI -…	Wrightmedicaltechnologyinc	2005	—

Also cleared against K111678: 7 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K172617	Treace Medical Concepts (TMC) Compression Screw System	Treace Medical Concepts, Inc.	2017	11
K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	I.T.S. GmbH	2022	3
K163489	OrthoSolutions 'System26' Bone Screws	Ortho Solutions UK Limited	2017	3
K143365	Eminent Foot Plate System	Eminent Spine	2015	1
K142418	I.T.S. Hand Locking Plates System - HLS	I.T.S. GmbH	2014	1
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026	0
K151241	Synchro-Medical TIGER TRACK Screw System	Synchro Medical	2015	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-1605-2026	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).
Jan 23, 2026	Class II	Z-1606-2026	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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
25 of the 151 ancestors have a recall of any class.
Of its descendants, K172617 (Treace Medical Concepts, Inc., 2017) has gone furthest, with 11 descendants of its own.
7 other devices also cite its predicate K111678.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 intended use of the 1.r.S- Exte mit Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories: The iTS. FLS- Foot Locking Plates Syste Is Indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag…

Read the full statement (328 words)

The intended use of the 1.r.S- Exte mit Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:

The iTS. FLS- Foot Locking Plates Syste Is Indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.

The 1.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicorlical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; wail osteotomy; fusion pf the first metatarsalphalangeal joint and interphalageal joint: fixation of osteotomies for Haliux Valgus treatment (such as Scarf, Chevron, etc.); Aikin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, maileolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.

And for sizes 4.3mmn or larger Is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication, Not for spinal use

The IT.S. HOL - Hallux Osteotomy Locking Plate System is Indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 250. Not for spinal use.

The I.TS. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Well-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131722: I.T.S. Extremity Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131722

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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