510(k) · Cleared
Recalled · Class II · 2015Biomet Sports Medicine Anchor Devices and Ziploop Constructs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 11, 2008 as substantially equivalent to K973015 (Bonutti Research, 1997) and 12 other predicates after a 149-day review. Its family tree reaches back 4 generations to 1995. 6 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 11, 2008
- Review
- 149 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 8
- Predicates
- 13
Its longest line of descent runs back 4 generations to K943806 (1995). 32 ancestors in all, the oldest K813581 (1982). 6 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 3 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- 2 generations backK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
- 1 generation backK061389 Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
- This deviceK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
- Descendant · cites it directly · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK130351 Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · cites it directly2descendants
- K193402ALLthread PEEK Suture AnchorBiomet, Inc. · 2020 · cites it directly0descendants
- K192942ALLthread Titanium Suture AnchorBiomet, Inc. · 2020 · cites it directly0descendants
- K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine · 2013 · cites it directly0descendants
- K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −3 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| −2 | K033355 | Lactoscrew Screw Anchor | Biomet Orthopedics, Inc. | 2004 | — |
| −1 | K061389 | Allthread Lactosorb Suture Anchor | Arthrotek, Inc. | 2006 | — |
| 0 (this device) | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing, Inc. | 2008 | — |
| +1 | K110473 | Nanotack Suture Anchor 1.4MM | Pivot Medical | 2011 | — |
| +1 | K193402 | ALLthread PEEK Suture Anchor | Biomet, Inc. | 2020 | — |
| +1 | K192942 | ALLthread Titanium Suture Anchor | Biomet, Inc. | 2020 | — |
| +1 | K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless… | Biomet Sports Medicine | 2013 | 2 |
| +2 | K130351 | Nanotack Suture Anchor 1.4MM with Flex Inserter | Pivot Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2020 | 2 | 0 |
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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
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 | Decided |
|---|---|---|---|
| * | K973015 | Multitak SS Suture SystemSummary page 1…er, fixation, biodegradable, soft tissue (21 CFR888.3030), Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Multitak Suture System TM - K973015 (Bonutti Research, Inc.), Cruciate Ligament Button - K813581 (Biomet, Inc.), BioRaptor 2.9mm Suture Ancho… | 1997 |
| * | K813581 | Cruciate Ligament ButtonSummary page 1…ted Devices To Which Substantial Equivalence Is Claimed: Multitak Suture System TM - K973015 (Bonutti Research, Inc.), Cruciate Ligament Button - K813581 (Biomet, Inc.), BioRaptor 2.9mm Suture Anchors - K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Blom… | 1982 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…Multitak Suture System TM - K973015 (Bonutti Research, Inc.), Cruciate Ligament Button - K813581 (Biomet, Inc.), BioRaptor 2.9mm Suture Anchors - K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Blomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.),… | 2006 |
| * | K012503 | Metal Screw AnchorSummary page 1…Inc.), Cruciate Ligament Button - K813581 (Biomet, Inc.), BioRaptor 2.9mm Suture Anchors - K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Blomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.), ALLthread TM Titanium - K042460 (Blomet, Inc.),… | 2001 |
| * | K061657 | Hitch Lactosorb Suture AnchorSummary page 1…1 (Biomet, Inc.), BioRaptor 2.9mm Suture Anchors - K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Blomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.), ALLthread TM Titanium - K042460 (Blomet, Inc.), ALLthreadT M PEEK K060693 and K071569(B… | 2006 |
| * | K042460 | TI - Screw Anchor SPSummary page 1…- K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Blomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.), ALLthread TM Titanium - K042460 (Blomet, Inc.), ALLthreadT M PEEK K060693 and K071569(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, In… | 2004 |
| * | K060693 | Microstrike and Allthread Peek Suture AnchorSummary page 1…- K012503 (Blomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.), ALLthread TM Titanium - K042460 (Blomet, Inc.), ALLthreadT M PEEK K060693 and K071569(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Bio… | 2006 |
| * | K071569 | Allthread Peek Anchor with Tantalum MarkerSummary page 1…lomet, Inc.), HitchTM L-15 - K061657 (Biomet, Inc.), ALLthread TM Titanium - K042460 (Blomet, Inc.), ALLthreadT M PEEK K060693 and K071569(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.)… | 2007 |
| * | K061389 | Allthread Lactosorb Suture AnchorSummary page 1…lomet, Inc.), ALLthreadT M PEEK K060693 and K071569(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax TM - K040475 (Bi… | 2006 |
| * | K012872 | Resorbable Screw AnchorSummary page 1…d K071569(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax TM - K040475 (Biomet, Inc.), HitchTM L-15 - K061657(Biomet… | 2001 |
| * | K033355 | Lactoscrew Screw AnchorSummary page 1…(Biomet, Inc.), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax TM - K040475 (Biomet, Inc.), HitchTM L-15 - K061657(Biomet, Inc.),… | 2004 |
| * | K061801 | 2.8 & 3.5MM Lactoscrew Suture AnchorsSummary page 1….), Hitch TM PEEK - K060693(Biomet, Inc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax TM - K040475 (Biomet, Inc.), HitchTM L-15 - K061657(Biomet, Inc.), Device Desc… | 2006 |
| * | K040475 | Micromax Suture AnchorSummary page 1…nc.), ALLthreadTM Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax TM - K040475 (Biomet, Inc.), HitchTM L-15 - K061657(Biomet, Inc.), Device Description: The Blomet Sports MedicineTM suture ancho… | 2004 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2015 | Class II | Z-1364-2015 | Employee error | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed. |
| Jan 25, 2012 | Not classified | Z-1236-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1235-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1233-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1237-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1231-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1232-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
| Jan 25, 2012 | Not classified | Z-1234-2012 | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K110473 (Pivot Medical, 2011) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K973015.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Ti-Screw, ALLthread TM Titanium, ALLthread TM PEEK and Hitch TM1 PEEK Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows: Shoulder: Acromlo-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion…
Read the full statement (932 words)
Ti-Screw, ALLthread TM Titanium, ALLthread TM PEEK and Hitch TM1 PEEK Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder: Acromlo-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Eplcondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread TM Titanium and ALLthread MT PEEK anchors), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Ulnar/Radlal Collateral Ligament Reconstruction (only for Ti-Screw, ALLthreadTM Titanium and ALLthread TM PEEK), Volar Plate Reconstruction
Hip: Labral
ALLthread Tm L-15, LactoScrew® L-15, MicroMax TM and Hitch L-15 Suture Anchors are Indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows:
Shoulder: Acromlo-Clavicular Separation, Anterior Shoulder Instabllty Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repalrs/Reconstruction, Midfoot / Forefoot Reconstruction/Repairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread& L-15), Illlotlblal Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Pateliar Realignment / Repair, Posterior Oblique Ligament Repair, VM0 Advancement
Hand and Wrist: Collateral ligament Repair (Gamekeeperes Thumb) (not Including Hitchy' L-15-), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanm (not including HitchTm L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread' L-15 and LactoScrew ® L-15), Volar Plate Reconstruction (not Including Hitch' m L-15)
Hip: Labral
Full, Bowtie and Half ZipLoopim Constructs are Indicated for use in soft tissue reattachment procedures-in the shoulder, wrist/hand, ankolefoot, elbow, knee, and hip.
When a ZIpLoop Tm Construct Ispackaged separately, the specific indications for use are as follows:
Shoulder: Acromlo-Clavicular Separation, Anterior Shoulder instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Delti Repair, Rotator Cuff Repair, SL.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair[ Reconstruction, Hallux Vaigus Reconstruction, Lateral/Medial Stabilization Repairs /Reconstruction, Mldfoot/Forefoot Reconstruction IRepairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitls Repair (Tnnis Elbow Riepi) Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for 2-0 or larger UHMWIPE Full or Bowtle ZipLoop7- Construc) Illiotiblal Band Tenodesis Joint Capsule Closure, LaterallMedial Collateral Uigament Repair, Patellar LIgament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral ILigament Repair (Gamekeeperes Thumb), Scapholurnate Ligament Reconstruction, Tendon Transfers InPhalax Ulnar/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and BoteZ0op osrc) oa Plt Reconstruction
Hip: Labral
When a Z~pLoop~m Construct is~packaged With~a Blormet Sports Medicine N interal fixation device, please refer to the package insert included with the surgeon' choice of internal fixation device for specific IndIcations.
Ti-Sarew ALLthread~T' Titanium, ALLthread Tm PEEK and Hitch 1 m PEEK Anchors with ZipLoop Constructs ~are Indicated for soft tissue reattachment procedures In the shoulder, footankle', elbow, knee, hand/wrist, and hip. Specific indicatios are as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuf Repair, S.LA.P Lesion Repairs
Foot and Ankle:. Achilles TendIon Repair/RecOnIstruction, Hailux Valgus Reconstruction, Lateral/Medial Stabilization Repairsfkeconstructlon, Mldifoot/Forefoot ReconstructiohlRepairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondy'litis Repair (Tennis Elbow Repaid, ulnar & Radial Collateral Ligament Reconstruction
Knee:W ACL/PCL (Wly for AL1LthreadTM- Titan Ium and ALLthreadlM PEEK anchors In conjunction with 2-0 or larger UHM'WPE Full or B1wtie ZIpLoop- Construct), I1llotiblal Band Tenodesis, Joint:Capsule Closure, Lateral/Medial Collateral Ligament Repair, PMAtei Ligament Repair, Patellar Tendon $Repairs,Patelar Reainment / Repair, Posterior ObIque Ligament Repair, 'VMO Advancement
Hand and Wrist-. Collateral LIgament Repair (Gamekeeper's Thumb), Scapholun to Ligament Reconstruction, Tendon Transfer InPhalanx, Ulntar/Radlal Collatera Ugaet RcO~htrcton (Only for TI-Srew ALLthread"1M TItanum and AILLthreadl- PEEK in conjuncton, with 2-0 or,larger URt4WPE Full or Bowtie. ZpLoopot4 Cnstruct); Volar Plate Reconstruction
Hip: Labral
ALLthread Tm L-15, LactoScrewO L-15, MicroMax Tmand Hitch"M L-15 Suture Anchors with ZipLoop Constructs are indicated for soft tissue reattachment procedures inthe shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair / Reconstruction, H-allux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs
Elbow Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs., Lateral Epicondylitis Repair (Tnnis Elbow Repair), Ulnar:& Radial Collateral Ligament Ronstructin
Knee ACL/PCL (only' for AI.LthreadTM1 L-15 Inconjunction with 2-0 or larger UHMWPE Full or BowVetleZLoop' TM Construct), Ililotiblal Band Tenhodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Paiteliar Ligament~Repair, Patellar Tendon Repailr, Patelair Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral'Ligament Repair (Gamekeeper's Thumb) (not including Hitch'Tm L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch'Tm L-15), Unar/Radial Collateral Ligament Reconstruction (only for AM~threadT " L-15 and LactoScrew~ L-15In conjuntion with 2-0or larger UHMWPE Pull or Bo itieZip-Looptm Construct), Volar Plate Reconstruction (not including Hitchi m L-15)
HIP-j.Labral
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080088
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