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510(k) Data Aggregation
K Number
K071816Device Name
HARPOON SUTURE ANCHOR
Manufacturer
BIOMET SPORTS MEDICINE, INC.
Date Cleared
2007-09-20
(80 days)
Product Code
HWC, JDR, MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET SPORTS MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:
Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair
Wrist - Scapholunate ligament reconstruction
Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair
Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement
Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction
Hip - Capsular Repair (acetabular labral repair)
Device Description
The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.
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K Number
K071704Device Name
SLEEVE AND BUTTON SOFT TISSUE DEVICES
Manufacturer
BIOMET SPORTS MEDICINE, INC.
Date Cleared
2007-09-17
(88 days)
Product Code
MBI, JDR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET SPORTS MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:
Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction
Device Description
The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.
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K Number
K070389Device Name
PEEK KNOTLESS ANCHORS
Manufacturer
BIOMET SPORTS MEDICINE, INC.
Date Cleared
2007-08-09
(181 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET SPORTS MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
Device Description
The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.
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K Number
K071498Device Name
SUBTALAR IMPLANT
Manufacturer
BIOMET SPORTS MEDICINE, INC.
Date Cleared
2007-07-31
(61 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET SPORTS MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:
- Symptomatic acquired flat foot treatment in children and adolescents .
- Symptomatic congenital flexible flat foot .
- Tarsal coalitions when associated with the flatfoot deformity .
- Posterior tibial tendon dysfunction with supple feet .
- Paralytic flat foot .
- Subtalar Instability .
- Severely pronated foot .
Device Description
The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.
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