510(k) · Cleared

Cleared

Synthes Cannulated Angle Blade Plate (Cabp) System

K974537510(k) TraditionalCleared Feb 18, 199877-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

Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Feb 18, 1998 as substantially equivalent to K954289 (Synthes (Usa), 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995. 110 later devices descend from it.

Decided: Feb 18, 1998
Review: 77 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954289 (1995). 110 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK954289 Synthes Cannulated Angle Blade PlateSynthes (Usa) · 1995
This deviceK974537 Synthes Cannulated Angle Blade Plate (Cabp) SystemSynthes (Usa) · 1998
Descendant · cites it directly · 98 of its ownK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
Descendant · 2 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
Descendant · 3 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
Descendant · 3 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
Descendant · 3 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2004high 15 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 110 · See all

K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · cites it directly98descendants
K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 2 generations on73descendants
K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 3 generations on69descendants
K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 3 generations on56descendants
K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 3 generations on53descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954289	Synthes Cannulated Angle Blade Plate	Synthes (Usa)	1995	—
0 (this device)	K974537	Synthes Cannulated Angle Blade Plate (Cabp) System	Synthes (Usa)	1998	—
+1	K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	10
+2	K073375	Newdeal Tibiaxys System	Newdeal Sas	2008	2
+3	K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…	Smith & Nephew, Inc.	2011	—
+3	K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	2010	—
+3	K121425	Ortholoc 3DI Ankle Fusion Plating System	Wrightmedicaltechnologyinc	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2007	4	0
2008	1	0
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2014	4	0
2015	1	0
2016	1	0
2017	9	0
2018	4	0
2019	7	0
2020	8	0
2021	12	0
2022	3	0
2023	15	0
2024	11	0
2025	9	0
2026	13	0

FIG. 1 — Lineage of K974537, 1995–2026Source: 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 KTT? 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 KTT device

#1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
#2 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
*	K954289	Synthes Cannulated Angle Blade Plate Summary page 1 …Sheri L. Musgnung Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class II, 21 CFR 888.3030; 888.3040 Synthes Cannulated Angle Blade Plate System (K954289) The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal…	Synthes (Usa)	1995	—

What descends from it? (110)

See all 110

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

Number	Device	Applicant	Decided	Descendants
K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	98
K192745	DePuy Synthes Trauma Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2019	5
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	4

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?

Its one ancestor has no recall.
Of its descendants, K033639 (Acumed, LLC, 2004) has gone furthest, with 98 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

The Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions.

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/K974537 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974537: Synthes Cannulated Angle Blade Plate (Cabp) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974537

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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