510(k) · Cleared

Cleared

Orthopedic Plate System

K972219510(k) TraditionalCleared Nov 20, 1997161-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

Ferguson Medical · HRS Plate, Fixation, Bone

Cleared on Nov 20, 1997 as substantially equivalent to K770128 (Howmedica Corp., 1977) and 17 other predicates after a 161-day review. Its family tree reaches back 1 generation to 1977. 8 later devices descend from it.

Decided: Nov 20, 1997
Review: 161 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 19

Its longest line of descent runs back 1 generation to K770128 (1977). 18 ancestors in all. 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK770128 B.G. Compression SystemHowmedica Corp. · 1977
This deviceK972219 Orthopedic Plate SystemFerguson Medical · 1997
Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
Descendant · 2 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
Descendant · 2 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
Descendant · 3 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007
Descendant · 3 generations on · 0 of its ownK063033 Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002high 3 (2005) · low 0 (2003)2026

Most influential descendants

Showing 5 of 8 · See all

K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 2 generations on1descendant
K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 2 generations on1descendant
K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 3 generations on0descendants
K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770128	B.G. Compression System	Howmedica Corp.	1977	—
0 (this device)	K972219	Orthopedic Plate System	Ferguson Medical	1997	—
+1	K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	—
+2	K063709	TS-Bone Hip Tool	Orthopedic Sciences, Inc.	2007	—
+2	K040850	Tsy Shoulder Plate Implant	Orthopedic Sciences, Inc.	2004	—
+3	K072175	Titanium Hip Tool Locking Plate	Orthopedic Sciences, Inc.	2007	—
+3	K063033	Modification to Titanium Shoulder Plate Implant	Orthopedic Sciences, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	2	0
1987	1	0
1989	1	0
1990	1	0
1991	1	0
1992	3	0
1993	3	0
1994	4	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	3	0
2006	1	0
2007	2	0

FIG. 1 — Lineage of K972219, 1977–2007Source: 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? (19)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K770128	B.G. Compression System Summary page 1 …te, fixation, bone Common/usual name: Plate, bone plate, etc. Proprietary name: Orthopedic Plate System B. Substantial equivalence: Howmedica, B.G. Compression System (K770128), DePuy, Inc. Distribution Center, Multiplicity of Products (K782123), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291…	Howmedica Corp.	1977	—
*	K782123	Multiplicity of Products Summary page 1 …tary name: Orthopedic Plate System B. Substantial equivalence: Howmedica, B.G. Compression System (K770128), DePuy, Inc. Distribution Center, Multiplicity of Products (K782123), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate (K862224),…	Depuy, Inc.	1979	—
*	K792291	Synthes Reconstructive Plates 'Y' Plates Summary page 1 …e: Howmedica, B.G. Compression System (K770128), DePuy, Inc. Distribution Center, Multiplicity of Products (K782123), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate (K862224), Kirschner Medical Corp., Kirschner Small Fragment Fixation S…	Synthes (Usa)	1979	—
Kept off the family tree	K862224	FDA’s K862224 is The Woog and the Woog D. Powered Toothbrushes Our OCR of the scanned summary read K862224, FDA’s number for The Woog and the Woog D. Powered Toothbrushes (Xouth, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate”. Kept off the family tree. Summary page 1 …ibution Center, Multiplicity of Products (K782123), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate (K862224), Kirschner Medical Corp., Kirschner Small Fragment Fixation System (K864924), Acufex Microsurgical, Inc., Acufex Cannulated Scre…	Xouth, Inc.	1986	—
*	K864924	Kirschner (R) Small Fragment Fixation System Summary page 1 …uctive Plates "Y" Plates (K792291), Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate (K862224), Kirschner Medical Corp., Kirschner Small Fragment Fixation System (K864924), Acufex Microsurgical, Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641), Onyx Medical Corp., Broad Self-Compressin…	Kirschner Medical Corp.	1987	—
*	K890641	Acufex Cannulated Screws, Washers, Bone Plates Summary page 1 …Plate (K862224), Kirschner Medical Corp., Kirschner Small Fragment Fixation System (K864924), Acufex Microsurgical, Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641), Onyx Medical Corp., Broad Self-Compressing Plate (K903252), Surgical Implants, Inc., May Humerus Plates (K912936), Link America…	Acufex Microsurgical, Inc.	1989	—
*	K903252	Broad Self-Compressing Plate Summary page 1 …agment Fixation System (K864924), Acufex Microsurgical, Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641), Onyx Medical Corp., Broad Self-Compressing Plate (K903252), Surgical Implants, Inc., May Humerus Plates (K912936), Link America, Schwabe Radius Plates (K914803), The Anspach Effort, Inc.,…	Onyx Medical Corp.	1990	—
*	K912936	May Humerus Plates Summary page 1 …Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641), Onyx Medical Corp., Broad Self-Compressing Plate (K903252), Surgical Implants, Inc., May Humerus Plates (K912936), Link America, Schwabe Radius Plates (K914803), The Anspach Effort, Inc., Anspach Mini-Plating System (K921338), Alphatec Manufa…	Turnkey Intergration USA, Inc.	1991	—
*	K914803	Schwabe Radius Plates Summary page 1 …Plates (K890641), Onyx Medical Corp., Broad Self-Compressing Plate (K903252), Surgical Implants, Inc., May Humerus Plates (K912936), Link America, Schwabe Radius Plates (K914803), The Anspach Effort, Inc., Anspach Mini-Plating System (K921338), Alphatec Manufacturing, Inc., Alphatec Compression and Reconst…	Link America, Inc.	1992	—
*	K921338	Anspach Mini-Plating System Summary page 1 …e (K903252), Surgical Implants, Inc., May Humerus Plates (K912936), Link America, Schwabe Radius Plates (K914803), The Anspach Effort, Inc., Anspach Mini-Plating System (K921338), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K922167), Howmedica, Luhr Pan Fixation System (K9…	The Anspach Effort, Inc.	1993	—
*	K922167	Alphatec Compression and Reconstruction Plates Summary page 1 …e Radius Plates (K914803), The Anspach Effort, Inc., Anspach Mini-Plating System (K921338), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K922167), Howmedica, Luhr Pan Fixation System (K923861), Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085), Smith…	Alphatec Mfg., Inc.	1992	—
*	K923861	Luhr Pan Fixation System Summary page 1 …Inc., Anspach Mini-Plating System (K921338), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K922167), Howmedica, Luhr Pan Fixation System (K923861), Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085), Smith Nephew Richards, Inc., Variable Angular Hold Bo…	Howmedica Corp.	1993	—
*	K924085	Reconstruction Plate System Summary page 1 …Alphatec Compression and Reconstruction Plates (K922167), Howmedica, Luhr Pan Fixation System (K923861), Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085), Smith Nephew Richards, Inc., Variable Angular Hold Bone Plate System (K930480), Ace Medical 3407 Bav Avenue ¢ Chico, Californi…	Sofamor Danek Mfg., Inc.	1992	—
*	K930480	Variable Angular Hold Bone Plate System Summary page 1 …ixation System (K923861), Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085), Smith Nephew Richards, Inc., Variable Angular Hold Bone Plate System (K930480), Ace Medical 3407 Bav Avenue ¢ Chico, California 95973 « USA Company, Ace Universal Reconstruction Plate (K9305…	Smith & Nephew Richards, Inc.	1994	—
*	K930592	Ace Universal Reconstruction Plate Summary page 2 …iable Angular Hold Bone Plate System (K930480), Ace Medical 3407 Bav Avenue ¢ Chico, California 95973 « USA Company, Ace Universal Reconstruction Plate (K930592), Baumer Ortopedia Ltd., Bagmer Plates (K930966), Onyx Medical Corp., Multiple Fragment Plate (K931687), Alphatec Manufacturing,…	Ace Medical Co.	1993	—
*	K930966	Baumer Plates Summary page 2 …Ace Medical 3407 Bav Avenue ¢ Chico, California 95973 « USA Company, Ace Universal Reconstruction Plate (K930592), Baumer Ortopedia Ltd., Bagmer Plates (K930966), Onyx Medical Corp., Multiple Fragment Plate (K931687), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction P…	Baumer Ortopedia, Ltd.	1994	—
*	K931687	Multiple Fragment Plate Summary page 2 …USA Company, Ace Universal Reconstruction Plate (K930592), Baumer Ortopedia Ltd., Bagmer Plates (K930966), Onyx Medical Corp., Multiple Fragment Plate (K931687), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K933112), Synthes, Volar Distal Radial Plate (K9…	Onyx Medical Corp.	1994	—
*	K933112	Alphatec Compression and Reconstruction Plates Summary page 2 …edia Ltd., Bagmer Plates (K930966), Onyx Medical Corp., Multiple Fragment Plate (K931687), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K933112), Synthes, Volar Distal Radial Plate (K953644). C. Device Description: The device is an assortment of various sizes and configu…	Alphatec Mfg., Inc.	1994	—
*	K953644	Volar Distal Radius Plate Summary page 2 …l Corp., Multiple Fragment Plate (K931687), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K933112), Synthes, Volar Distal Radial Plate (K953644). C. Device Description: The device is an assortment of various sizes and configurations of stainless steel bone plates. D. Int…	Synthes (Usa)	1996	—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	7

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?

None of the 18 ancestors has a recall.
Of its descendants, K022139 (Orthopedic Sciences, Inc., 2002) has gone furthest, with 7 descendants of its own.

How does its category compare?

All HRS devices

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

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 device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

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/K972219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972219: Orthopedic 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/K972219

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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