510(k) · Cleared

Cleared

Bionx Distal Radius Screw

K974876510(k) TraditionalCleared Mar 20, 199881-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

Bionx Implants, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Mar 20, 1998 as substantially equivalent to K792022 (Zimmer, Inc., 1979) and 4 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1979. 419 later devices descend from it.

Decided: Mar 20, 1998
Review: 81 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K792022 (1979). 5 ancestors in all. 419 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
This deviceK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
Descendant · cites it directly · 413 of its ownK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
Descendant · cites it directly · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
Descendant · 2 generations on · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005

Showing 5 of 419 descendants. See all descendants

Descendants cleared per year

1999high 39 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 419 · See all

K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999 · cites it directly413descendants
K012001SmartscrewBionx Implants, Ltd. · 2001 · cites it directly337descendants
K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · 2 generations on333descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792022	Herbert Bone Screw	Zimmer, Inc.	1979	6
0 (this device)	K974876	Bionx Distal Radius Screw	Bionx Implants, Inc.	1998	—
+1	K992947	Cannulated Smartscrew Models 224540C, 224570C	Bionx Implants, Ltd.	1999	—
+1	K012001	Smartscrew	Bionx Implants, Ltd.	2001	—
+2	K030900	Inion Otps Biodegradable Fixaton System	Inion, Ltd.	2003	—
+3	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+4	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0
2002	4	0
2003	2	0
2004	4	0
2005	5	0
2006	4	0
2007	2	0
2008	7	0
2009	9	0
2010	3	0
2011	8	0
2012	5	0
2013	12	0
2014	20	0
2015	11	0
2016	8	0
2017	22	0
2018	20	0
2019	34	0
2020	30	0
2021	26	0
2022	28	0
2023	36	0
2024	39	0
2025	39	0
2026	38	0

FIG. 1 — Lineage of K974876, 1979–2026Source: 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 MAI? 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 MAI device

#1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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? (5)

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
*	K792022	Herbert Bone Screw Summary page 1 …ed Distal Radius Screw Common or Usual Name Bionx Distal Radius Screw Classification Name Bone Screw (87 HWC) o Predicate Devices 1) Zimmer, Inc. Herbert Bone Screw (K792022) (“Herbert Bone Screw”) 2) Synthes Dorsal Distal Radius Plate System (K962616) (“Synthes Dorsal Plate”) 3) Synthes Volar Distal…	Zimmer, Inc.	1979	6
*	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System Summary page 1 …ication Name Bone Screw (87 HWC) o Predicate Devices 1) Zimmer, Inc. Herbert Bone Screw (K792022) (“Herbert Bone Screw”) 2) Synthes Dorsal Distal Radius Plate System (K962616) (“Synthes Dorsal Plate”) 3) Synthes Volar Distal Radius Plate (K953644) (“Synthes Volar Plate”) 4) Zimmer, Inc. Forte Distal R…	Synthes (Usa)	1996	—
*	K953644	Volar Distal Radius Plate Summary page 1 …rbert Bone Screw (K792022) (“Herbert Bone Screw”) 2) Synthes Dorsal Distal Radius Plate System (K962616) (“Synthes Dorsal Plate”) 3) Synthes Volar Distal Radius Plate (K953644) (“Synthes Volar Plate”) 4) Zimmer, Inc. Forte Distal Radius Plate (K953714) (“Zimmer Forte Plate”) N\\\DC - 8366774 - 0015378.…	Synthes (Usa)	1996	—
*	K953714	Zimmer Reconstruction System Symphyseal Bone Plate Summary page 1 …adius Plate System (K962616) (“Synthes Dorsal Plate”) 3) Synthes Volar Distal Radius Plate (K953644) (“Synthes Volar Plate”) 4) Zimmer, Inc. Forte Distal Radius Plate (K953714) (“Zimmer Forte Plate”) N\\\DC - 8366774 - 0015378.01 MAR-17-98 17:43 From:HOGAN & HARTSON DC v18 202-637-5910…	Zimmer, Inc.	1995	—
*	K961608	Synthes (U.S.a.) Polypin Summary page 2 …“Zimmer Forte Plate”) N\\\DC - 8366774 - 0015378.01 MAR-17-98 17:43 From:HOGAN & HARTSON DC v18 202-637-5910 T-380 P.21721 Job-703 5) Synthes Polypin (K961608) Intended Use The Bionx Distal Radius Screw is intended for use in the fixation of cancellous bone fractures in combination wit…	Synthes (Usa)	1997	—

Also cleared against K792022: 17 other devices →

What descends from it? (419)

See all 419

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

Number	Device	Applicant	Decided	Descendants
K992947	Cannulated Smartscrew Models 224540C, 224570C	Bionx Implants, Ltd.	1999	413
K012001	Smartscrew	Bionx Implants, Ltd.	2001	337
K013057	Biocuff,C, Models 236018, 236028, 236036	Bionx Implants, Inc.	2001	79
K023022	Nugen FX Screw	Bionx Implants, Inc.	2002	2
K020222	Wisorb Malleolar Screw	Cambridge Scientific, Inc.	2002	2
K032447	Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded	Linvatec Biomaterials, Ltd.	2004	1
K020819	Distal Radius Plating System	Biomet, Inc.	2002	1
K050388	Refix Internal Fracture Fixation Screws	Xtremi-T, LLC	2005	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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K992947 (Bionx Implants, Ltd., 1999) has gone furthest, with 413 descendants of its own.
17 other devices also cite its predicate K792022.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The Bionx Biodegradable, Threaded Distal Radius Screw is intended for use in the fixation of cancellous bone fractures in combination with appropriate postoperative cast immobilization. The device will specifically be indicated for use in open reduction and internal fixation of Frykman type I - IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius.

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/K974876 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974876: Bionx Distal Radius Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974876

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