510(k) Report

510(k) · Cleared

Cleared

Bio-Anchor

K964805510(k) TraditionalCleared Jun 9, 1997192-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

Linvatec Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jun 9, 1997 as substantially equivalent to K953954 (Linvatec Corp., 1996) after a 192-day review. Its family tree reaches back 1 generation to 1996. 81 later devices descend from it.

Decided
Jun 9, 1997
Review
192 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K953954 (1996). 81 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1998: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared1999: 1 descendant cleared2009: 6 descendants cleared2008: 1 descendant cleared2010: 3 descendants cleared2011: 3 descendants cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2013: 3 descendants cleared2019: 6 descendants cleared2026: 2 descendants cleared2020: 5 descendants cleared2016: 1 descendant cleared2014: 3 descendants cleared2015: 2 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants clearedK953954 · Preloaded Soft Tissue Anchor · Linvatec Corp. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 7 descendants4 generations forward: 14 descendants5 generations forward: 15 descendants6 generations forward: 21 descendants7 generations forward: 12 descendants8 generations forward: 6 descendants K953954 · Preloaded Soft Tissue Anchor · Linvatec Corp. · 19960+5
  1. Root · 1 generation backK953954 Preloaded Soft Tissue AnchorLinvatec Corp. · 1996
  2. This deviceK964805 Bio-AnchorLinvatec Corp. · 1997
  3. Descendant · cites it directly · 80 of its ownK983186 Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998
  4. Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
  5. Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  6. Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
  7. Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 12003: 12004: 12006: 12008: 12009: 62010: 32011: 32012: 22013: 32014: 32015: 22016: 12017: 72018: 42019: 62020: 52021: 42022: 42023: 82024: 32025: 82026: 2
1998high 8 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 81 · See all
  • K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998 · cites it directly80descendants
  • 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
  • K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953954Preloaded Soft Tissue AnchorLinvatec Corp.1996—
0 (this device)K964805Bio-AnchorLinvatec Corp.1997—
+1K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp.1998—
+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—
+2K053561Bio-Mini Revo Suture AnchorConmed Linvatec2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200310
200410
200610
200810
200960
201030
201130
201220
201330
201430
201520
201610
201770
201840
201960
202050
202140
202240
202380
202430
202580
202620
FIG. 1 — Lineage of K964805, 1996–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K953954Preloaded Soft Tissue Anchor
Summary page 3
…Anchor bone fixation diameter Linvatec: Suture: Non- Gamma Preloaded Soft Tissue absorbable Sterilization | Suture: Anchor Braided Polyester USP sizes #0 to #2 510(k) # K953954 Predicate: Bio-Anchor Soft tissue to Poly (L-lactic) Single-Use 3.5mm diameter bone fixation acid Linvatec: ETO Suture: Bio-Ancho…
Linvatec Corp.1996—
*—Bio-Anchor
Named without a submission number
—

Also cleared against K953954: 2 other devices →

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp.199880
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?

  • Its one ancestor has no recall.
  • Of its descendants, K983186 (Linvatec Corp., 1998) has gone furthest, with 80 descendants of its own.
  • 2 other devices also cite its predicate K953954.

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 Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction. Shoulder 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or…

Read the full statement (143 words)

The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

Shoulder

1. Bankart lesion repairs

2. SLAP lesion repairs

3. Acromio-clavicular separation repairs

4. Rotator cuff tear repairs

5. Capsular shift or capsulolabral reconstructions

6. Biceps tenodesis

7. Deltoid repairs

Foot and Ankle

1. Hallux Valgus repairs

2. Medial or lateral instability repairs/reconstructions

3. Achilles tendon repairs/reconstructions

4. Midfoot reconstructions

Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions

2. Ulnar or radial collateral ligament reconstructions

3. Tennis elbow repair

4. Biceps tendon reattachment

Knee

1. Extra-capsular repairs and reattachments of:

a. medial collateral ligament

b. lateral collateral ligament

c. posterior oblique ligament or joint capsule to tibia

d. joint capsule closure to anterior proximal tibia

2. Extracapsular reconstruction, iliotibial band tenodesis

3. Patellar realignment and tendon repairs

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

Also cleared against K953954

2 other devices cite the same predicate.

  • K991024Bone Bullet Suture AnchorLinvatec Corp. · 1999
  • K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998

More from Linvatec Corp.

93 FDA decisions under this applicant name. See the company

  • K092998Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 20091 recall
  • K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
  • K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp. · 2009
  • K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave…Linvatec Corp. · 2009

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/K964805 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964805: Bio-Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964805

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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