510(k) · Cleared

Recalled · Class II · 2019

Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws

K060710510(k) TraditionalCleared Apr 26, 200641-day reviewClass II21 CFR 888.3040Recalls 5

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

Zimmer, Inc. · HWC Screw, Fixation, Bone

Cleared on Apr 26, 2006 as substantially equivalent to K000684 (Synthes (Usa), 2000) after a 41-day review. Its family tree reaches back 1 generation to 2000. 1 of the 189 devices in its family, counting itself, has a Class I recall. 187 later devices descend from it. It has been recalled 5 times.

Decided: Apr 26, 2006
Review: 41 days
Class: Class II
Product code: HWC
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K000684 (2000). 187 later devices descend from it, 11 citing it directly. 1 of the 189 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
This deviceK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006
Descendant · cites it directly · 160 of its ownK082527 Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc. · 2008 · Recalled
Descendant · cites it directly · 146 of its ownK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
Descendant · cites it directly · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017

Showing 5 of 187 descendants. See all descendants

Descendants cleared per year

2006high 28 (2026) · low 0 (2007)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 187 · See all

K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc. · 2008 · cites it directly160descendants
K063303Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · cites it directly146descendants
K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · cites it directly135descendants
K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
0 (this device)	K060710	Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws	Zimmer, Inc.	2006	—
+1	K082527	Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws	Zimmer, Inc.	2008	5
+1	K063303	Universal Locking System, 2.7MM Plates & Screws	Zimmer, Inc.	2006	4
+1	K112885	Zimmer Plates and Screws System Screws Only	Zimmer, Inc.	2011	15
+2	K143039	CrossRoads Screw System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	—
+3	K162825	CAPTIVATE™ Compression Screws	Globus Medical, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	1	0
2010	1	0
2011	4	0
2012	3	0
2013	4	0
2014	7	0
2015	15	0
2016	8	0
2017	8	0
2018	5	0
2019	8	0
2020	10	0
2021	12	1
2022	12	0
2023	15	0
2024	22	0
2025	21	0
2026	28	0

FIG. 1 — Lineage of K060710, 2000–2026Source: 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.

1 device in this family has a Class I recall. 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (2)

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 …(Pre-amendment device). Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684, cleared April 28, 2000). Device Description: The Zimmer Universal L…	Synthes (Usa)	2000	1
*	—	Zimmer® ECT® Internal Fracture Fixation system Named without a submission number			—

Also cleared against K000684: 68 other devices →

What descends from it? (187)

See all 187

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

Number	Device	Applicant	Decided	Descendants
K082527	Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws	Zimmer, Inc.	2008	160
K063303	Universal Locking System, 2.7MM Plates & Screws	Zimmer, Inc.	2006	146
K112885	Zimmer Plates and Screws System Screws Only	Zimmer, Inc.	2011	135
K081759	NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…	Zimmer GmbH	2008	21
K140508	Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws	Zimmer, Inc.	2014	14
K151407	RECON system	Normed Medizin-Technik GmbH	2015	4
K152312	RECON system-V-TEK-IVP Plates and Screws	Normed Medizin-Technik GmbH	2015	2
K120651	Stabiliz Fixation System	Stabiliz Orthopaedics, LLC	2012	1
K201229	Intai Anatomic Locking Plate and Screw System	Intai Technology Corporation	2022	0
K160633	G3(TM) Active Plate (R) Small Fragment System	Genesis Fracture Care, Inc.	2016	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 10, 2019	Class II	Z-0312-2020	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
May 4, 2016	Class II	Z-1673-2016	Packaging change control	A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Jan 11, 2016	Class II	Z-1106-2016	Packaging	As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Dec 9, 2015	Class II	Z-0654-2016	Labeling Change Control	The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
Oct 11, 2013	Class II	Z-1042-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K082527 (Zimmer, Inc., 2008) has gone furthest, with 160 descendants of its own.
68 other devices also cite its predicate K000684.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Universal Locking Plate System is indicated for temporary internal fixation and

stabilization of osteotomies and fractures, including;

* Comminuted fractures

* Supracondylar fractures

* Extra-articular fractures

* Fractures in osteopenic bone

* Nonunions

* Malunions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060710 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060710

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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