# K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Jun 11, 2008 after 149 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943806 (1995). 32 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973015: Multitak SS Suture System, Bonutti Research (1997) Summary page 1.
- K813581: Cruciate Ligament Button, Biomet, Inc. (1982) Summary page 1.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.
- K012503: Metal Screw Anchor, Biomet Manufacturing, Inc. (2001) Summary page 1.
- K061657: Hitch Lactosorb Suture Anchor, Arthrotek, Inc. (2006) Summary page 1.
- K042460: TI - Screw Anchor SP, Arthrotek, Inc. (2004) Summary page 1.
- K060693: Microstrike and Allthread Peek Suture Anchor, Arthrotek, Inc. (2006) Summary page 1.
- K071569: Allthread Peek Anchor with Tantalum Marker, Biomet, Inc. (2007) Summary page 1.
- K061389: Allthread Lactosorb Suture Anchor, Arthrotek, Inc. (2006) Summary page 1.
- K012872: Resorbable Screw Anchor, Arthrotek, Inc. (2001) Summary page 1.
- K033355: Lactoscrew Screw Anchor, Biomet Orthopedics, Inc. (2004) Summary page 1.
- K061801: 2.8 & 3.5MM Lactoscrew Suture Anchors, Arthrotek, Inc. (2006) Summary page 1.
- K040475: Micromax Suture Anchor, Biomet, Inc. (2004) Summary page 1.

## Most influential descendants
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own
- K193402: ALLthread PEEK Suture Anchor (2020), 0 descendants of its own
- K192942: ALLthread Titanium Suture Anchor (2020), 0 descendants of its own
- K123485: Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof (2013), 0 descendants of its own
- K130351: Nanotack Suture Anchor 1.4MM with Flex Inserter (2013), 0 descendants of its own

## Recalls of this device
- Feb 26, 2015 · Class II · Z-1364-2015: 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 b
- Jan 25, 2012 · Not classified · Z-1236-2012: 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-
- Jan 25, 2012 · Not classified · Z-1235-2012: 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-
- Jan 25, 2012 · Not classified · Z-1233-2012: 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-
- Jan 25, 2012 · Not classified · Z-1237-2012: 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-
- Jan 25, 2012 · Not classified · Z-1231-2012: 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-
- Jan 25, 2012 · Not classified · Z-1232-2012: 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-
- Jan 25, 2012 · Not classified · Z-1234-2012: 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-

## Indications for use
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

Source page: https://510kreport.com/device/K080088
Methodology: https://510kreport.com/methodology