510(k) · Cleared

Cleared

Wolf Long Bone Plate System

K131834510(k) TraditionalCleared Nov 4, 2013137-day reviewClass II21 CFR 888.3030

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

Toby Orthopaedics · HRS Plate, Fixation, Bone

Cleared on Nov 4, 2013 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 3 other predicates after a 137-day review. Its family tree reaches back 4 generations to 1998.

Decided: Nov 4, 2013
Review: 137 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K981372 (1998). 20 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
This deviceK131834 Wolf Long Bone Plate SystemToby Orthopaedics · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K981372	Synthes 3.0 MM PC-Fix System	Synthes (Usa)	1998	—
−3	K991407	Synthes Locking Calcaneal Plates	Synthes (Usa)	1999	—
−2	K033669	Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)	Smith & Nephew, Inc.	2003	1
−1	K082807	Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…	Synthes (Usa)	2008	—
0 (this device)	K131834	Wolf Long Bone Plate System	Toby Orthopaedics	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1998	1	0
1999	1	0
2000	5	0
2001	4	0
2004	1	0
2011	1	0

FIG. 1 — Lineage of K131834, 1998–2013Source: 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? (4)

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
*	K082807	Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications Summary page 1 …1 CFR 888.3030 - Single / multiple component metallic bone fixation appliances and accessories Predicate Devices: Synthes LCP System - K082807 Synthes %/3TubularDCL Plate - K01 1335 Acumed Congruent Bone Plate System -…	Synthes (Usa)	2008	—
*	K011335	Synths One-Third Tubular DCL Plate Summary page 1 …metallic bone fixation appliances and accessories Predicate Devices: Synthes LCP System - K082807 Synthes %/3TubularDCL Plate - K01 1335 Acumed Congruent Bone Plate System - K012655, K102998 Device Description:…	Synthes (Usa)	2001	2
*	K012655	Congruent Bone Plate System Summary page 1 …s: Synthes LCP System - K082807 Synthes %/3TubularDCL Plate - K01 1335 Acumed Congruent Bone Plate System - K012655, K102998 Device Description: The TOBY® WOLF® Long Bone Plate system consists…	Acu Med, Inc.	2001	16
*	K102998	Congruent Bone Plate System Summary page 1 …807 Synthes %/3TubularDCL Plate - K01 1335 Acumed Congruent Bone Plate System - K012655, K102998 Device Description: The TOBY® WOLF® Long Bone Plate system consists of implantable titanium al…	Acumed, LLC	2011	—

Also cleared against K082807: 42 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
6 of the 20 ancestors have a recall of any class.
42 other devices also cite its predicate K082807.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 WOLF® Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131834: Wolf Long Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131834

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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