510(k) · Cleared

Recalled · Class II · 2020

A. L. P. S. Clavicle Plating System

K173767510(k) TraditionalCleared Apr 6, 2018116-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

Biomet, Inc. · HRS Plate, Fixation, Bone

Cleared on Apr 6, 2018 as substantially equivalent to K083843 (DePuy Orthopaedics, Inc., 2009) after a 116-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it. It has been recalled 2 times.

Decided: Apr 6, 2018
Review: 116 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K083843 (2009). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK083843 Locking Anatomic & Composite Plating SystemDePuy Orthopaedics, Inc. · 2009 · Recalled
This deviceK173767 A. L. P. S. Clavicle Plating SystemBiomet, Inc. · 2018
Descendant · cites it directly · 2 of its ownK210192 A.L.P.S. Clavicle Plating SystemBiomet, Inc. · 2021
Descendant · 2 generations on · 1 of its ownK250494 The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies · 2025
Descendant · cites it directly · 0 of its ownK254288 Clavicle Fixation SystemSkeletal Dynamics, Inc. · 2026
Descendant · 3 generations on · 0 of its ownK251913 OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies · 2025

Most influential descendants

Showing 4 of 4 · See all

K210192A.L.P.S. Clavicle Plating SystemBiomet, Inc. · 2021 · cites it directly2descendants
K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies · 2025 · 2 generations on1descendant
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc. · 2026 · cites it directly0descendants
K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K083843	Locking Anatomic & Composite Plating System	DePuy Orthopaedics, Inc.	2009	2
0 (this device)	K173767	A. L. P. S. Clavicle Plating System	Biomet, Inc.	2018	—
+1	K210192	A.L.P.S. Clavicle Plating System	Biomet, Inc.	2021	—
+2	K250494	The OsteoCentric Bone Plate and Screw System	OsteoCentric Technologies	2025	—
+1	K254288	Clavicle Fixation System	Skeletal Dynamics, Inc.	2026	—
+3	K251913	OsteoCentric® UnifiMI® TCS Plating System	OsteoCentric Technologies	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K173767, 2009–2026Source: 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

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What was it cleared against? (1)

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
*	K083843	Locking Anatomic & Composite Plating System Summary page 4 …metallic bone fixation appliances and accessories (21 CFR 888.3030) Predicate Device(s): K083843 Locking Anatomic Depuy & Composite Orthopae…	DePuy Orthopaedics, Inc.	2009	2

Also cleared against K083843: 4 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K210192	A.L.P.S. Clavicle Plating System	Biomet, Inc.	2021	2
K254288	Clavicle Fixation System	Skeletal Dynamics, Inc.	2026	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 23, 2020	Class II	Z-0882-2021	Device Design	The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
May 14, 2020	Class II	Z-2308-2020	Device Design	Distributed to the field without having completed design history files or design transfer activities

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K210192 (Biomet, Inc., 2021) has gone furthest, with 2 descendants of its own.
4 other devices also cite its predicate K083843.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.

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/K173767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173767: A. L. P. S. Clavicle Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173767

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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