510(k) · Cleared

Cleared

Distal Radius Fracture Fixation Plate

K981715510(k) TraditionalCleared Jul 29, 199875-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

Avanta Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 29, 1998 as substantially equivalent to K943853 (Wrightmedicaltechnologyinc, 1995) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Jul 29, 1998
Review: 75 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K943853 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK943853 Distal Radius Fracture Fixation Plate SystemWrightmedicaltechnologyinc · 1995
This deviceK981715 Distal Radius Fracture Fixation PlateAvanta Orthopaedics, Inc. · 1998
Descendant · cites it directly · 0 of its ownK990596 Distal Radius Fracture Fixation Plate SystemAvanta Orthopaedics, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990596Distal Radius Fracture Fixation Plate SystemAvanta Orthopaedics, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943853	Distal Radius Fracture Fixation Plate System	Wrightmedicaltechnologyinc	1995	—
0 (this device)	K981715	Distal Radius Fracture Fixation Plate	Avanta Orthopaedics, Inc.	1998	—
+1	K990596	Distal Radius Fracture Fixation Plate System	Avanta Orthopaedics, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K981715, 1995–1999Source: 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? (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
*	K943853	Distal Radius Fracture Fixation Plate System Summary page 1 …ion Plate System Device Classification: Class II Reviewing Panel: Orthopaedic Regulation Number 888.3030 Product Code: 87HRS Accessories Predicate Device: Orthomet K943853 Synthes K953644 Device Description: The distal radius plate like the predicate device includes various size plates, right, left…	Wrightmedicaltechnologyinc	1995	—
*	K953644	Volar Distal Radius Plate Summary page 1 …Device Classification: Class II Reviewing Panel: Orthopaedic Regulation Number 888.3030 Product Code: 87HRS Accessories Predicate Device: Orthomet K943853 Synthes K953644 Device Description: The distal radius plate like the predicate device includes various size plates, right, left, small, large,…	Synthes (Usa)	1996	—

Also cleared against K943853: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K990596	Distal Radius Fracture Fixation Plate System	Avanta Orthopaedics, Inc.	1999	0

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 2 ancestors has a recall.
Of its descendants, K990596 (Avanta Orthopaedics, Inc., 1999) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K943853.

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 intended use of the distal radius fracture fixation plate system is internal fixation of

fractures and osteotomies of the distal radius. This may include:

Displaced or non-displaced fracture which may or may not involve angulation or

fragmentation of bone,

Failed fracture fixation with or without bone graft,

Osteotomy and repair of distal radius malunion with or without bone graft.

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/K981715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981715: Distal Radius Fracture Fixation Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981715

Report an extraction error

Are you the manufacturer?

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