Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are intended for use In soft Intended DSC. District oper of it the shoulder, foot / ankle, elbow, knee, hand / wrist, and hip. The Biomet suture anchor devices have similar indications for use with one Indication for Use statement for nonresorbable anchor devices and another for resorbable anchor devices. ZipLoop™ Constructs may be (esoraged separately (one Indication for Use Statement covers a ZipLoop™ Construct packaged separately) or preloaded on suture anchors In place of sutures (an Indication for Use statement for non-resorbable anchor device with ZipLoop™ Construct and another for a resorbable anchor device with a ZipLoop™ Construct). Specific indications for use are as follows:

Anchor devices without ZipLoop Constructs:
Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors
Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ 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: 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, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow: Blceps 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™ Titanlum and ALLthread™ PEEK anchors), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Reallgnment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx, Ulnar/Radial Collateral Ligament Reconstruction Acconstraction) Tenash Titanium and ALLthread™ PEEK), Volar Plate Reconstruction
Hip: Labral

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors
ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hltch™ 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: 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, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/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), 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) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch™ L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15}, Volar Plate Reconstruction (not Including Hitch™ L-15)
Hip: Labral

ZipLoop™ Constructs packaged separately:
Device Name: Full, Bowtie and Half Zip-Loop™ Constructs
Full, Bowtle and Half ZipLoop™ Constructs are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip.
When a ZipLoop™ Construct is packaged separately, the specific Indications for use are 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, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs / 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 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblal 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/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and Bowtie ZipLoop™ Construct), Volar Plate Reconstruction
Hip: Labral
When a ZipLoop™ Construct Is packaged with a Blomet Sports Medicine™ internal fixation device, please refer to the package insert included with the surgeon's choice of internal fixation device for specific indications.

Anchor devices packaged with ZlpLoop™ Constructs:
Device Name: Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs
Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs are Indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder: Acromio-Clavlcular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Blceps 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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ PEEK anchors in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblai 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/Radial Collateral Ligament Reconstruction (only for Tl-Screw, ALLthread™ Titanium and ALLthread™ PEEK In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct); Volar Plate Reconstruction
Hip: Labral

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs
ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs 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: 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, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs
Elbow: Bloeps 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 in conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), Illiotiblal 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) (not including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not Including Hitch™ L-15), Uinar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15 In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Volar Plate Reconstruction (not including Hitch™ L-15)
Hip: Labral

Device Description

The Blomet Sports Medicine™ suture anchor devices (Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK, ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15) Suture Anchors are internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation due to injury or degenerative disease. The devices are available preloaded with suture and / or a ZipLoop™ Construct.
The Biomet Sports Medicine™ ZipLoop™ Constructs provide a flexible, adjustable means of soft tissue The blomer in a manner that does not require the surgeon to the a knot in sutures. The ZipLoop™ Constructs are available in three configurations and two strand materials.

AI/ML Overview

The information provided is a 510(k) Summary for Biomet Sports Medicine™ Anchor devices and ZipLoop™ Constructs. This document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device.

Therefore, many of the requested categories related to acceptance criteria, clinical study design, and performance metrics are not applicable or not provided in this type of submission.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The 510(k) Summary states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use." However, specific acceptance criteria (e.g., tensile strength, pull-out force thresholds) and the quantitative results (reported device performance) from this non-clinical testing are not detailed. The submission relies on demonstrating that the technological characteristics (material, design, sizing) are "similar or identical" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not provided. The document mentions "Non-clinical laboratory testing" but does not specify the sample size for these tests.
Data Provenance: The nature of the non-clinical tests suggests laboratory testing. Country of origin is not specified, and it is inherently retrospective in the sense that the testing would have been completed prior to this submission. It is not prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since this is a non-clinical submission demonstrating substantial equivalence to predicate devices, there isn't a "ground truth" establishment in the context of expert review of data like in image-based diagnostic AI. The "ground truth" in this context would be the performance characteristics of the predicate devices themselves, and the non-clinical tests would aim to show the new devices perform comparably.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, no expert adjudication process is described for this type of submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document is for medical devices (suture anchors and constructs), not for AI/diagnostic software, so an MRMC comparative effectiveness study is not relevant and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This pertains to medical hardware, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly defined in the context of expert review. For non-clinical performance testing of mechanical devices, the "ground truth" refers to established engineering standards, material specifications, and the known performance of the predicate devices. The study aimed to show the new devices meet functional requirements comparable to these benchmarks.

8. The sample size for the training set

Not applicable. This submission is for mechanical medical devices, not an AI algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, this question is not relevant.

Summary

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K080088

JUN 1 1 2008

Image /page/0/Picture/2 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the next. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font.

510(k) Summary

January 11, 2008 Preparation Date:

Biomet Sports Medicine, Inc.(formerly known as Arthrotek, Inc.) Applicant/Sponsor:

Contact Person: Robert R. Friddle

Biomet Sports Medicine™ Anchor devices and ZipLoop™ Constructs Proprietary Name:

Soft tissue anchor Common Name:

Fastener, fixation, nondegradable, soft tissue (21 CFR 888.3040); Screw, Classification Name: fixation, bone (21 CFR 888.3040); Suture, nonabsorbable, synthetic, polyester (21CFR878.5000); Suture, nonabsorbable, synthetic, polyethylene (21CFR878.5000); Clip, implantable (21 CFR 878.4300); Marker, radiographic, implantable (21 CFR 878.4300); Staple, fixation, bone (21 CFR 888.3030); Fastener, fixation, biodegradable, soft tissue (21 CFR888.3030),

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Multitak Suture System™ - K973015 (Bonutti Research, Inc.), Cruciate Ligament Button - K813581 (Biomet, Inc.), BioRaptor 2.9mm Suture Anchors - K053344 (Smith & Nephew, Inc.), Ti-Screw - K012503 (Biomet, Inc.), Hitch™ L-15 - K061657 (Biomet, Inc.), ALLthread™ Tltanium - K042460 (Biomet, Inc.), ALLthread™ PEEK K060693 and K071569(Biomet, Inc.), Hitch™ PEEK - K060693(Biomet, Inc.), ALLthread™ Lactosorb® - K061389 (Biomet, Inc.) LactoScrew® L-15 - K012872, K033355 and K061801 (Biomet, Inc.) MicroMax™ - K040475 (Biomet, Inc.), Hitch™ L-15 - K061657(Biomet, Inc.),

Device Description: The Blomet Sports Medicine™ suture anchor devices (Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK, ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15) Suture Anchors are internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation due to injury or degenerative disease. The devices are available preloaded with suture and / or a ZipLoop™ Construct.

The Biomet Sports Medicine™ ZipLoop™ Constructs provide a flexible, adjustable means of soft tissue The blomer in a manner that does not require the surgeon to the a knot in sutures. The ZipLoop™ Constructs are available in three configurations and two strand materials.

Intended Use: Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are intended for use In soft Intended DSC. District oper of it the shoulder, foot / ankle, elbow, knee, hand / wrist, and hip. The Biomet

Mailing Address: P.O. Box 587 Warsaw IN 46581 0587 Tel: Fren' 200 348 9500 Official 474 257 6939 Main Fax: 574 287 8137 25:47 Granet.com

Shipping Address: 56 East Bell Dove Warsen, IN 46582

5 - Page 1 of 5

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suture anchor devices have similar indications for use with one Indication for Use statement for nonresorbable anchor devices and another for resorbable anchor devices. ZipLoop™ Constructs may be (esoraged separately (one Indication for Use Statement covers a ZipLoop™ Construct packaged separately) or preloaded on suture anchors In place of sutures (an Indication for Use statement for non-resorbable anchor device with ZipLoop™ Construct and another for a resorbable anchor device with a ZipLoop™ Construct). Specific indications for use are as follows:

Anchor devices without ZipLoop Constructs:

Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors

Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ 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: 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, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs

Elbow: Blceps 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™ Titanlum and ALLthread™ PEEK anchors), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Reallgnment / Repair, Posterior Oblique Ligament Repair, VMO Advancement

Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx, Ulnar/Radial Collateral Ligament Reconstruction Acconstraction) Tenash Titanium and ALLthread™ PEEK), Volar Plate Reconstruction

Hip: Labral

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors

ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hltch™ 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:

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

{2}------------------------------------------------

Knee: ACL/PCL (only for ALLthread™ L-15), 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) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not Including Hitch™ L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15}, Volar Plate Reconstruction (not including Hitch™ L-15)

Hip: Labral

ZipLoop™ Constructs packaged separately:

Device Name: Full, Bowtie and Half Zip-Loop™ Constructs

Full, Bowtle and Half ZipLoop™ Constructs are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip.

When a ZipLoop™ Construct is packaged separately, the specific Indications for use are as follows:

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), 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/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and Bowtie ZipLoop™ Construct), Volar Plate Reconstruction

Hip: Labral

When a ZipLoop™ Construct Is packaged with a Blomet Sports Medicine™ internal fixation device, please refer to the package insert included with the surgeon's choice of internal fixation device for specific indications.

Anchor devices packaged with ZlpLoop™ Constructs:

Device Name: Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs

Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs are Indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:

{3}------------------------------------------------

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ PEEK anchors in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), 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/Radial Collateral Ligament Reconstruction (only for Tl-Screw, ALLthread™ Titanium and ALLthread™ PEEK In conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct); Volar Plate Reconstruction

Hip: Labral

ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with Device Name: ZipLoop Constructs

ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs are indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows:

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for ALLthread™ L-15 in conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), 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) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch™ L-15), Unar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15 in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Volar Plate Reconstruction (not Including Hitch™ L-15)

Hip: Labrai

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Summary of Technologies: The technological characteristics (material, design and sizing) of the current suture anchor devices are not changed and are similar or identical to the predicate devices. The technological characteristics of the new ZipLoop™ Constructs (material, design, sizing and Indications) are similar or identical to the suture constructs provided pre-loaded with predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Blomet, Inc. unless otherwise specificed. Multitak Suture System™ is a trademark of Bonutti Research Corporation. PEEK-OPTIMA® is a registered trademark of Inviblo, Inc. BloRaptor™ Is a trademark of Smith&Nephew.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Mr. Robert R. Friddle Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

JUN 1 1 2008

K080088 Trade/Device Name: Expanded indications for Biomet Sports Medicine™ Anchor Devices and ZipLoop™ Constructs Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI, JDR, MAI Dated: May 16, 2008 Received: May 19, 2008

Dear Mr. Friddle:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{6}------------------------------------------------

Page 2 - Mr. Robert R. Friddle

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mellema

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko80088 510(k) Number (if known):

Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors

Indications for Use:

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ 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/Radial Collateral Ligament Reconstruction (only for TI-Screw, ALLthread™ Titanium and ALLthread™ PEEK), Volar Plate Reconstruction

Hip: Labral

YES Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Neike Ohe frank

and Neurological Devices

510(k) Number K080088

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510(k) Number (if known): K080088

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors

Indications for Use:

ALLthread™ L-15, LactoScrew® L-15, MicroMax™ 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:

Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs

Elbow: Blceps 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), Illiotibial Band Tenodesis, John 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) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch™ L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15}, Volar Plate Reconstruction (not Including Hitch™ L-15)

Hip: Labral

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page Dof 1

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Division of General, Restorative, and Neurological Devices

510(k) Number K080087

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510(k) Number (if known): K080044

Device Name: Full, Bowtie and Half Zip-Loop™ Constructs

Indications for Use:

Full, Bowtie and Half ZipLoop™ Constructs are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip.

When a ZipLoop™ Construct is packaged separately, the specific indications for use are as follows:

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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), Illiotiblal 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/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and Bowtie ZipLoop™ Construct), Volar Plate Reconstruction

Hip: Labral

When a ZlpLoop™ Construct is packaged with a Blomet Sports Medicine™ Internal fixation device, please refer to the package insert included with the surgeon's choice of internal fixation device for specific Indications.

YES Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K080088
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Page 3 of 5

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510(k) Number (if known): K010088

Device Name: TI-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs

Indications for Use:

Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs are indicated for soft tissue reattachment procedures in the shoulder, footfankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:

Shoulder: Acromio-Clavlcular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Blceps 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 Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ PEEK anchors in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblai 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/Radial Collateral Ligament Reconstruction (only for Tl-Screw, ALLthread™ Titanium and ALLthread™ PEEK In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct); Volar Plate Reconstruction

Hip: Labral

YES Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page of

Division of General, Restorative, and Neurological Devices

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510(k) Number K080088

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510(k) Number (if known): Koofoff

ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with Device Name: ZipLoop Constructs

Indications for Use:

Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs

Elbow: Bloeps 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 in conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), Illiotiblal 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) (not including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not Including Hitch™ L-15), Uinar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15 In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Volar Plate Reconstruction (not including Hitch™ L-15)

Hip: Labral

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)	Page 3 of 5
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K080088

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.