(149 days)
Not Found
No
The 510(k) summary describes mechanical surgical implants (suture anchors and constructs) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for soft tissue reattachment procedures due to injury or degenerative disease, which directly addresses a medical condition or disease.
No
The device description clearly states that these are "internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation due to injury or degenerative disease." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description clearly states that the devices are "internal fixation devices" and are available "preloaded with suture and / or a ZipLoop™ Construct," indicating they are physical hardware components used in surgical procedures.
Based on the provided text, the Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "soft tissue reattachment procedures" and "internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures." This describes a surgical implant used within the body to repair or reconstruct tissues.
- Device Description: The description reinforces this by calling them "internal fixation devices."
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Being used in a laboratory setting.
Therefore, these devices are classified as surgical implants or internal fixation devices, not IVDs.
N/A
Intended Use / Indications for Use
Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are intended for use In soft tissue reattachment procedures in 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 non-resorbable anchor devices and another for resorbable anchor devices. ZipLoop™ Constructs may be packaged 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-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™ 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:
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
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, JDR, MAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot / ankle, elbow, knee, hand / wrist, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K973015, K813581, K053344, K012503, K061657, K042460, K060693, K071569, K061389, K012872, K033355, K061801, K040475, K061657
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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
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:
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), 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
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™ 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:
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 Leslon 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 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
4
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
7
Ko80088 510(k) Number (if known):
Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors
Indications for Use:
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: 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
8
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:
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™ 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
Nail R.E. Ogil for mkm
Division of General, Restorative, and Neurological Devices
510(k) Number K080087
9
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:
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 Leslon 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 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 |
|---|---|
| --------------- | --------- |
Page 3 of 5
10
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
4-5
510(k) Number K080088
11
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:
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
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 |