510(k) · Cleared

Recalled · Class II · 2026

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

K210935510(k) TraditionalCleared Aug 31, 2022520-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. GmbH · HRS Plate, Fixation, Bone

Cleared on Aug 31, 2022 as substantially equivalent to K063166 (I.T.S. Implantat-Technologie-Systeme GmbH, 2006) and 7 other predicates after a 520-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it. It has been recalled once.

Decided: Aug 31, 2022
Review: 520 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 8

Its longest line of descent runs back 11 generations to K962616 (1996). 167 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
7 generations between
3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
1 generation backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
This deviceK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022
Descendant · cites it directly · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Descendant · cites it directly · 0 of its ownK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
Descendant · cites it directly · 0 of its ownK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025

Show all 11 generations

Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
1 generation backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
This deviceK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022

Most influential descendants

Showing 3 of 3 · See all

K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · cites it directly0descendants
K260054I.T.S. PRS Phoenix III.T.S. GmbH · 2026 · cites it directly0descendants
K241666EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−10	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−9	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−8	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−7	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−6	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−5	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−4	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
−3	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
−2	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
−1	K131722	I.T.S. Extremity Fixation Systems	I.T.S. GmbH	2013	2
0 (this device)	K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	I.T.S. GmbH	2022	—
+1	K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with…	I.T.S. GmbH	2026	—
+1	K260054	I.T.S. PRS Phoenix II	I.T.S. GmbH	2026	—
+1	K241666	EVOS Pelvic and Acetabular System	Smith & Nephew	2025	—

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	13	0
2001	13	0
2002	11	0
2003	6	0
2004	5	0
2005	14	0
2006	13	0
2007	7	0
2008	4	0
2009	5	0
2010	4	0
2011	1	0
2012	2	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0
2026	2	0

FIG. 1 — Lineage of K210935, 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? (8)

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
*	K063166	I.T.S. Pelvic Reconstruction System Summary page 5 …s II, (see 21 CFR Sec. 888.3040) DEVICE PRODUCT CODE: HRS, HWC, HTN SUBSTANTIAL EQUIVALENCE: PRIMARY PREDICATE I.T.S. - Pelvic Reconstruction System - PRS (K063166) ADDITIONAL PREDICATES I.T.S. - FLS Extremity System (K131722) Stryker – Trauma Pelvic Set…	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
*	K131722	I.T.S. Extremity Fixation Systems Summary page 5 …SUBSTANTIAL EQUIVALENCE: PRIMARY PREDICATE I.T.S. - Pelvic Reconstruction System - PRS (K063166) ADDITIONAL PREDICATES I.T.S. - FLS Extremity System (K131722) Stryker – Trauma Pelvic Set (K001614) Stryker – Pelvis II Implant Sy…	I.T.S. GmbH	2013	2
*	K001614	Stryker Trauma Pelvic Set Summary page 5 …ic Reconstruction System - PRS (K063166) ADDITIONAL PREDICATES I.T.S. - FLS Extremity System (K131722) Stryker – Trauma Pelvic Set (K001614) Stryker – Pelvis II Implant System (K131132) Synthes – 3.5mm Low Pro…	Howmedica Osteonics Corp.	2000	—
*	K131132	Pelvis II Implant System Summary page 5 …S. - FLS Extremity System (K131722) Stryker – Trauma Pelvic Set (K001614) Stryker – Pelvis II Implant System (K131132) Synthes – 3.5mm Low Profile Pelvic Reconstruction Plate (K031573) Sy…	Stryker Trauma AG	2013	—
*	K031573	Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate Summary page 5 …001614) Stryker – Pelvis II Implant System (K131132) Synthes – 3.5mm Low Profile Pelvic Reconstruction Plate (K031573) Synthes – 3.5mm Quadrilateral Surface Plates (K093928) Acumed – Pelv…	Synthes (Usa)	2003	—
*	K093928	Synthes 3.5MM Quadrilateral Surface Plates Summary page 5 …Synthes – 3.5mm Low Profile Pelvic Reconstruction Plate (K031573) Synthes – 3.5mm Quadrilateral Surface Plates (K093928) Acumed – Pelvic Bone Plate System (K122538) Synthes – 3.5mm Spring P…	Synthes (Usa)	2010	—
*	K122538	Acumed Pelvic Bone Plate System Summary page 5 …ion Plate (K031573) Synthes – 3.5mm Quadrilateral Surface Plates (K093928) Acumed – Pelvic Bone Plate System (K122538) Synthes – 3.5mm Spring Plate (K061973) DEVICE DESCRIPTION: The I.T.S. Pelvic Reconstruc…	Acumed, LLC	2012	1
*	K061973	Synthes 3.5MM Spring Plate Summary page 5 …drilateral Surface Plates (K093928) Acumed – Pelvic Bone Plate System (K122538) Synthes – 3.5mm Spring Plate (K061973) DEVICE DESCRIPTION: The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) enco…	Synthes (Usa)	2006	—

Also cleared against K063166: 5 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026
K260054	I.T.S. PRS Phoenix II	I.T.S. GmbH	2026
K241666	EVOS Pelvic and Acetabular System	Smith & Nephew	2025

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-1608-2026	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 26 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
32 of the 167 ancestors have a recall of any class.
Of its descendants, K260958 (I.T.S. GmbH, 2026) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K063166.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include: » Fractures of the acetabulum * Fractures of the pelvic ring * Fractures of the quadrilateral surface * Fractures of the sympyhsis * Fractures of the ilium * Fractures of the SIJ * [lio-iliac distance osteosynthesis »…

Read the full statement (260 words)

The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include:

» Fractures of the acetabulum

* Fractures of the pelvic ring

* Fractures of the quadrilateral surface

* Fractures of the sympyhsis

* Fractures of the ilium

* Fractures of the SIJ

* [lio-iliac distance osteosynthesis

» Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations

* Revision surgery of pseudoarthroses, non-unions and mal-unions

The I.T.S. PRS RX System is not intended for spinal use.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include:

* Fractures involving the Posterior Wall & Posterior Column

* Fractures involving the Anterior Column of the Acetabulum

* Fractures involving the Quadrilateral Surface

» Symphyseal Disruptions & Para-symphyseal Fractures

* Fractures of the ilium

* Fractures of the SIJ

* Dorsal neutralization plating for posterior pelvic ring fractures

» Osteotomies, arthrodesis and sacroiliac joint dislocations

* Revision surgery of pseudoarthroses, non-unions and mal-unions

The I.T.S. PRS Phoenix System is not intended for spinal use.

Indications for use of the I.T.S. Infra-acetabular screw placement include:

* Fractures involving the anterior column, e.g. anterior column, anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures

The I.T.S. Infra-acetabular screw is not intended for spinal use.

Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include:

* Pelvic fractures

The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.

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/K210935 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210935

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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