Search Results
Found 4 results
510(k) Data Aggregation
K Number
K140970Device Name
ONE-PIECE PEEK FUSION IMPLANT
Manufacturer
MTP SOLUTIONS LLC
Date Cleared
2014-05-13
(27 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MTP SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Device Description
The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.
Ask a Question
K Number
K133235Device Name
THREADED PEEK K-WIRE
Manufacturer
MTP SOLUTIONS LLC
Date Cleared
2014-04-07
(168 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MTP SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
Device Description
Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.
Ask a Question
K Number
K133515Device Name
PEEK FUSION IMPLANT
Manufacturer
MTP SOLUTIONS LLC
Date Cleared
2014-03-28
(133 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MTP SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Device Description
The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.
Ask a Question
K Number
K133229Device Name
TITANIUM SUTURE ANCHOR
Manufacturer
MTP SOLUTIONS LLC
Date Cleared
2014-01-30
(101 days)
Product Code
MBI, THE
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MTP SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair
Device Description
The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.
Ask a Question
Page 1 of 1