510(k) Report

510(k) · Cleared

Cleared

Biofix Biodegradable Threaded Suture Anchor

K972783510(k) TraditionalCleared Apr 14, 1998263-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 Apr 14, 1998 as substantially equivalent to K950875 (American Medical Electronics, Inc., 1995) and 4 other predicates after a 263-day review. Its family tree reaches back 2 generations to 1990. 166 later devices descend from it.

Decided
Apr 14, 1998
Review
263 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K904436 (1990). 8 ancestors in all. 166 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1995: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestor2002: 4 descendants cleared1998: 1 descendant cleared2003: 1 descendant cleared2004: 2 descendants cleared2006: 3 descendants cleared1999: 2 descendants cleared2007: 2 descendants cleared2008: 3 descendants cleared2005: 1 descendant cleared2009: 6 descendants cleared2010: 4 descendants cleared2011: 5 descendants cleared2025: 23 descendants cleared2024: 16 descendants cleared2012: 4 descendants cleared2015: 5 descendants cleared2013: 5 descendants cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 18 descendants cleared2019: 6 descendants cleared2026: 14 descendants cleared2022: 8 descendants cleared2016: 3 descendants cleared2014: 7 descendants cleared2020: 5 descendants cleared2021: 7 descendants clearedK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 13 descendants4 generations forward: 23 descendants5 generations forward: 26 descendants6 generations forward: 28 descendants7 generations forward: 19 descendants8 generations forward: 14 descendants9 generations forward: 14 descendants10 generations forward: 17 descendants11 generations forward: 2 descendants K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 19900+5+10
  1. Root · 2 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 1 generation backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. This deviceK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
  4. Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
  5. Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
  6. Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
  7. Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  8. Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004

Showing 5 of 166 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22002: 42003: 12004: 22005: 12006: 32007: 22008: 32009: 62010: 42011: 52012: 42013: 52014: 72015: 52016: 32017: 72018: 42019: 62020: 52021: 72022: 82023: 182024: 162025: 232026: 14
1998high 23 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 166 · See all
  • K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
  • K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · cites it directly77descendants
  • K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 2 generations on76descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
0 (this device)K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998—
+1K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.1998—
+2K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments1999—
+1K020056Duet Suture AnchorBionx Implants, Ltd.2002—
+1K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.2003—
+2K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models…Linvatec Biomaterials, Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199520
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200240
200310
200420
200510
200630
200720
200830
200960
201040
201150
201240
201350
201470
201550
201630
201770
201840
201960
202050
202170
202280
2023180
2024160
2025230
2026140
FIG. 1 — Lineage of K972783, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K950875Ogden Anchor
Summary page 1
…Usual Name Bionx Suture Anchor Classification Name Biodegradable Soft Tissue F: ixation Fastener Predicate Devices (1) American Medical Electronics, Inc. Ogden Anchor (K950875) (2) Zimmer, Inc. Statak® Soft Tissue Attachment Device (K962397) 3) Arthrex, Inc. FASTak™ Suture Anchor (K960516) (4) Mitek Sur…
American Medical Electronics, Inc.1995—
*K962397Statak Soft Tissue Attachment Device
Summary page 1
…Soft Tissue F: ixation Fastener Predicate Devices (1) American Medical Electronics, Inc. Ogden Anchor (K950875) (2) Zimmer, Inc. Statak® Soft Tissue Attachment Device (K962397) 3) Arthrex, Inc. FASTak™ Suture Anchor (K960516) (4) Mitek Surgical Products, Inc. GII Anchor (K953877) (5) Smith & Nephew End…
Zimmer, Inc.1996—
*K960516Fastak Suture Anchor
Summary page 1
…s (1) American Medical Electronics, Inc. Ogden Anchor (K950875) (2) Zimmer, Inc. Statak® Soft Tissue Attachment Device (K962397) 3) Arthrex, Inc. FASTak™ Suture Anchor (K960516) (4) Mitek Surgical Products, Inc. GII Anchor (K953877) (5) Smith & Nephew Endoscopy, Inc. Acufex® TAG Suture Anchor (K961555)…
Arthrex, Inc.1996—
*K953877Mitek Gii Anchor
Summary page 1
…K950875) (2) Zimmer, Inc. Statak® Soft Tissue Attachment Device (K962397) 3) Arthrex, Inc. FASTak™ Suture Anchor (K960516) (4) Mitek Surgical Products, Inc. GII Anchor (K953877) (5) Smith & Nephew Endoscopy, Inc. Acufex® TAG Suture Anchor (K961555) \\\DC . 83547/6 - 0605220.01 Indication…
Mitek Surgical Products, Inc.1995—
*K961555Acufex Tag Bioabsorbable Anchors
Summary page 1
…) 3) Arthrex, Inc. FASTak™ Suture Anchor (K960516) (4) Mitek Surgical Products, Inc. GII Anchor (K953877) (5) Smith & Nephew Endoscopy, Inc. Acufex® TAG Suture Anchor (K961555) \\\DC . 83547/6 - 0605220.01 Indications for Use The Bionx Suture Anchor is indicated for use in arthroscopic…
Acufex Microsurgical, Inc.1996—

What descends from it? (166)

See all 166

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

NumberDeviceApplicantDecidedDescendants
K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886
K020056Duet Suture AnchorBionx Implants, Ltd.200278
K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377

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 8 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K982139 (Bionx Implants, Inc., 1998) has gone furthest, with 86 descendants of its own.

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

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
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

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Bionx Suture Anchor is indicated for use in arthroscopic or open surgical

procedures to reattach ligaments to the shoulder bone, i.e., for rotator cuff or

Bankart lesion repair. The device may be attached to either the articular facet

surface or to a metaphyseal region of the bone, provided that the thickness of the

cortex is less than 1.5 mm.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bionx Implants, Inc.

18 FDA decisions under this applicant name. See the company

  • K023022Nugen FX ScrewBionx Implants, Inc. · 2002
  • K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
  • K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
  • K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc. · 2001
  • K012334Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K972783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972783: Biofix Biodegradable Threaded Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972783

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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