510(k) · Cleared

Recalled · Class II · 2016

Zimmer Plates and Screws System Screws Only

K112885510(k) TraditionalCleared Dec 19, 201180-day reviewClass II21 CFR 888.3040Recalls 15

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 Dec 19, 2011 as substantially equivalent to K090047 (Synthes (Usa), 2009) and 7 other predicates after an 80-day review. Its family tree reaches back 3 generations to 2000. 1 of the 147 devices in its family, counting itself, has a Class I recall. 135 later devices descend from it. It has been recalled 15 times.

Decided: Dec 19, 2011
Review: 80 days
Class: Class II
Product code: HWC
Recalls: 15
Predicates: 8

Its longest line of descent runs back 3 generations to K000684 (2000). 11 ancestors in all, the oldest K874669 (1987). 135 later devices descend from it, 4 citing it directly. 1 of the 147 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
2 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
1 generation backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
This deviceK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011
Descendant · cites it directly · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Descendant · 2 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
Descendant · 4 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Descendant · cites it directly · 41 of its ownK124027 Monster Screw SystemApogee Orthosolutions · 2013

Showing 5 of 135 descendants. See all descendants

Descendants cleared per year

2013high 26 (2026) · low 1 (2013)2026

Class I recalls in this family

K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 135 · See all

K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly79descendants
K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 2 generations on74descendants
K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 4 generations on42descendants
K124027Monster Screw SystemApogee Orthosolutions · 2013 · cites it directly41descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−2	K060710	Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws	Zimmer, Inc.	2006	5
−1	K063303	Universal Locking System, 2.7MM Plates & Screws	Zimmer, Inc.	2006	4
0 (this device)	K112885	Zimmer Plates and Screws System Screws Only	Zimmer, Inc.	2011	—
+1	K143039	CrossRoads Screw System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	—
+2	K162825	CAPTIVATE™ Compression Screws	Globus Medical, Inc.	2017	—
+3	K171651	Excelsius GPS	Globus Medical, Inc.	2017	1
+4	K191100	ExcelsiusGPS Spine 1.1 Interbody Module	Globus Medical, Inc.	2019	—
+1	K124027	Monster Screw System	Apogee Orthosolutions	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1995	1	0
1998	1	0
2001	1	0
2006	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	3	0
2015	10	0
2016	2	0
2017	5	0
2018	2	0
2019	7	0
2020	8	0
2021	7	1
2022	9	0
2023	15	0
2024	21	0
2025	19	0
2026	26	0

FIG. 1 — Lineage of K112885, 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? (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
*	K090047	Synthes (Usa) 1.5MM Mini Fragment LCP System Summary page 1 …threaded metallic bone fixation fastener - 21 CFR 888.3040 Predicate Devices: Synthes 1.5mm Mini Fragment LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Unive…	Synthes (Usa)	2009	—
*	K952272	TI. Alloy 2.0 MM Cortex Screw Summary page 1 …888.3040 Predicate Devices: Synthes 1.5mm Mini Fragment LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K0607 10, K082527),…	Synthes (Usa)	1995	—
*	K063303	Universal Locking System, 2.7MM Plates & Screws Summary page 1 …LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K0607 10, K082527), Synthes 6.5mm Cancellous Screws (K06162 1), Pioneer…	Zimmer, Inc.	2006	4
*	K060710	Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws Summary page 1 …m (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K0607 10, K082527), Synthes 6.5mm Cancellous Screws (K06162 1), Pioneer…	Zimmer, Inc.	2006	5
*	K082527	Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws Summary page 1 …), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K0607 10, K082527), Synthes 6.5mm Cancellous Screws (K06162 1), Pioneer Cannula…	Zimmer, Inc.	2008	5
*	K061621	Synthes (Usa) 6.5 MM Cancellous Screws Summary page 1 …2272), Zimmer Universal Locking System (K063303, K0607 10, K082527), Synthes 6.5mm Cancellous Screws (K06162 1), Pioneer Cannulated Screw System (washer - K003496) and DePuy…	Synthes (Usa)	2006	—
*	K003496	Cannulated Screw System Summary page 1 …7 10, K082527), Synthes 6.5mm Cancellous Screws (K06162 1), Pioneer Cannulated Screw System (washer - K003496) and DePuy ACE Composite Locking Nut (K983265). Device Description: Temporary in…	Pioneer Surgical Technology	2001	1
*	K983265	Depuy Ace Composite Locking Nut Summary page 1 …s (K06162 1), Pioneer Cannulated Screw System (washer - K003496) and DePuy ACE Composite Locking Nut (K983265). Device Description: Temporary internal fixation devices, such as the ZPS screw…	Depuy Ace Medical Co.	1998	—

Also cleared against K090047: 17 other devices →

What descends from it? (135)

See all 135

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

Number	Device	Applicant	Decided	Descendants
K143039	CrossRoads Screw System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	79
K124027	Monster Screw System	Apogee Orthosolutions	2013	41
K140508	Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws	Zimmer, Inc.	2014	14
K142836	Zimmer Plates and Screws (ZPS), Forte Screws	Zimmer, Inc.	2014	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 4, 2016	Class II	Z-1677-2016	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-1108-2016	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.
Jan 11, 2016	Class II	Z-1111-2016	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.
Jan 11, 2016	Class II	Z-1116-2016	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.
Jan 11, 2016	Class II	Z-1102-2016	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.
Jul 22, 2014	Class II	Z-2247-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2249-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2251-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2246-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2248-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2245-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2250-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Jul 22, 2014	Class II	Z-2244-2014	Package design/selection	Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Oct 11, 2013	Class II	Z-1040-2014	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…
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…

The 5 latest of 15 recalls; the web page lists all.

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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
5 of the 11 ancestors have a recall of any class.
Of its descendants, K143039 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) has gone furthest, with 79 descendants of its own.
17 other devices also cite its predicate K090047.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112885 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112885: Zimmer Plates and Screws System Screws Only.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112885

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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