510(k) · Cleared

Recalled · Class II · 2015

Small Fragment Locking Plating System

K072083510(k) TraditionalCleared Oct 25, 200787-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

DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Oct 25, 2007 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1988. 37 later devices descend from it. It has been recalled 2 times.

Decided: Oct 25, 2007
Review: 87 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K882831 (1988). 3 ancestors in all. 37 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK882831 Ace Cancellous Bone ScrewBuckman Co., Inc. · 1988
This deviceK072083 Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc. · 2007
Descendant · cites it directly · 32 of its ownK101421 Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon…DePuy Orthopaedics, Inc. · 2010
Descendant · 2 generations on · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 4 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 2 generations on · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2010high 8 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all

K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…DePuy Orthopaedics, Inc. · 2010 · cites it directly32descendants
K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · 2 generations on17descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on11descendants
K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882831	Ace Cancellous Bone Screw	Buckman Co., Inc.	1988	—
0 (this device)	K072083	Small Fragment Locking Plating System	DePuy Orthopaedics, Inc.	2007	—
+1	K101421	Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates…	DePuy Orthopaedics, Inc.	2010	—
+2	K143697	Biomet Proximal Humerus Plating System	Biomet Manufacturing	2015	18
+3	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+4	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+2	K113733	Small and Large Fragments Osteosynthesis System Neofix	Neoortho Produtos Ortopedicos S/A	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2012	2	0
2014	3	0
2015	2	0
2017	2	0
2018	2	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	8	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K072083, 1988–2026Source: 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? (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
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 1 …(21 CFR § 888.3030) Predicate Devices: Small Fragment Dynamic Synthes K000684 Compression Locking (DCL) System…	Synthes (Usa)	2000	1
*	K882831	Ace Cancellous Bone Screw Summary page 1 …K000684 Compression Locking (DCL) System DePuy ACE K882831 Cancellous Bone Screws DePuy ACE K905048 3.'5mm Cortical Bone…	Buckman Co., Inc.	1988	—
*	K905048	Ace 3.5MM Cortical Bone Screw Summary page 1 …System DePuy ACE K882831 Cancellous Bone Screws DePuy ACE K905048 3.'5mm Cortical Bone Screws Intended Use:…	Ace Medical Co.	1991	—

Also cleared against K000684: 68 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K101421	Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…	DePuy Orthopaedics, Inc.	2010	32
K110086	Ifs Profile Plates, Screws, and Washers	Internal Fixation Systems, Inc.	2011	5
K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	1
K243761	A.L.P.S. Small Fragment Plating System	Biomet Orthopedics	2025	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2015	Class II	Z-0450-2016	Process change control	These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the…
Dec 19, 2013	Class II	Z-0716-2014	Labeling mix-ups	3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K101421 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 32 descendants of its own.
68 other devices also cite its predicate K000684.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072083: Small Fragment Locking Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072083

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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