510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

BIOSURE REGENESORB interference Screw

K142948510(k) TraditionalCleared Jan 13, 201595-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 13, 2015 as substantially equivalent to K140879 (Smith & Nephew, Inc., 2014) and 2 other predicates after a 95-day review. Its family tree reaches back 8 generations to 1996. It has been recalled once.

Decided
Jan 13, 2015
Review
95 days
Class
Class II
Product code
MAI
Recalls
1
Predicates
3

Its longest line of descent runs back 8 generations to K961555 (1996). 49 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2008: 1 other ancestor2012: 1 other ancestor2009: 2 other ancestors2007: 2 other ancestors2005: 3 other ancestors2004: 4 other ancestors2003: 2 other ancestors2001: 7 other ancestors2006: 2 other ancestors2000: 1 other ancestor1999: 3 other ancestors1995: 4 other ancestors1998: 4 other ancestors1996: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestorK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K061154 · Kinsa Suture Anchor · Smith & Nephew, Inc. · 2006K071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalledK082215 · Osteoraptor Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2008 · recalledK101459 · Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 · Smith & Nephew, Inc. · 2011K123393 · Healicoil Suture Anchor with Regenesorb · Smith & Nephew, Inc. · 2013199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 9 other ancestors4 generations back: 9 other ancestors5 generations back: 12 other ancestors K123393 · Healicoil Suture Anchor with Regenesorb · Smith & Nephew, Inc. · 2013K101459 · Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 · Smith & Nephew, Inc. · 2011K082215 · Osteoraptor Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2008 · recalledK071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalledK061154 · Kinsa Suture Anchor · Smith & Nephew, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−50
  1. Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 4 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
  6. 3 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
  7. 2 generations backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
  8. 1 generation backK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
  9. This deviceK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−7K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−6K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−5K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−4K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071
−3K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division20089
−2K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765…Smith & Nephew, Inc.2011—
−1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.2013—
0 (this device)K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199540
199620
199840
199930
200010
200170
200320
200440
200530
200620
200720
200810
200920
201210
201410
FIG. 1 — Lineage of K142948, 1996–2015Source: 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? (3)

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
*K140879Biosure Healicoil PK Interference Screw
Summary page 5
…e Device 510(k) Clearance Date Number BIOSURE HEALICOIL PK K140879 07/21/2014 Interference Screw PLLA/HA Screw (BIOSURE HA) K080358…
Smith & Nephew, Inc.2014—
*K080358Plla, HA Screw
Summary page 5
…BIOSURE HEALICOIL PK K140879 07/21/2014 Interference Screw PLLA/HA Screw (BIOSURE HA) K080358 12/14/2004 HEALICOIL Absorbable Suture K123393 4/11/2013 Anchor…
Smith & Nephew Inc., Endoscopy Div.20082
*K123393Healicoil Suture Anchor with Regenesorb
Summary page 5
…Interference Screw PLLA/HA Screw (BIOSURE HA) K080358 12/14/2004 HEALICOIL Absorbable Suture K123393 4/11/2013 Anchor (HEALICOIL REGENESORB) DEVICE DESCRIPTION The Smith & N…
Smith & Nephew, Inc.2013—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 24, 2025Class IIZ-0957-2026Packaging process controlRemoval of affected lot of screws due to labeling error.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 15 of the 49 ancestors have a recall of any class.

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. 2015, this device’s year, is highlighted.

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 BIOSURE REGENESORB Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications: Knee ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis Shoulder Acromioclavicular separation repairs Biceps…

Read the full statement (118 words)

The BIOSURE REGENESORB Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or

bone-tendon-bone for the following indications:

Knee

ACL repairs

PCL repairs

Extra-capsular repairs

Medial collateral ligament

Lateral collateral ligament

Posterior oblique ligament

Patellar realignment and tendon repairs

Vastus medialis obliquus advancement

Iliotibial band tenodesis

Shoulder

Acromioclavicular separation repairs

Biceps tenodesis

Foot and Ankle

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Flexor hullucis longus (FHL)

Tendon transfers

Elbow, Wrist, and Hand

Biceps tendon reattachment

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Scapholunate ligament reconstruction

Tendon transfers

Carpometacarpal joint arthroplasty

NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone

procedures.

Indications for use as stated in the FDA summary.

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K142948 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142948: BIOSURE REGENESORB interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142948

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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