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510(k) Data Aggregation
K Number
K020222Device Name
WISORB MALLEOLAR SCREW
Manufacturer
CAMBRIDGE SCIENTIFIC, INC.
Date Cleared
2002-07-29
(188 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
CAMBRIDGE SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WISORB™ malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense.
The WISORB™ malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the lateral malleolus, avulsion fractures of the medial malleolus (Dyputren; Danis-Weber Type-B), avulsion fractures of the posterior malleolus (Volkman's Triangle). Other fractures that maybe suitable for treatment with the WISORB™ malleolar screw include distal ractures (Type Colles), which typically occur at the metaphyseal portion of the bone proximal to the extensor tendon sheaths.
The WISORB™ malleolar screw is not intended for use in and is contraindicated for:
- Fractures of cortical bone (diaphyseal area)
- Situations of active or potential infection or where patient cooperation cannot be guaranteed.
Device Description
The WISORB™ malleolar screw is composed of 75% by wt (88% by volume) of the copolymer (L -co-D,L-lactide) (weight ratio 70:30), and 25% by wt (12% by volume) of sintered hydroxylapatite. The WISORB is a bioabsorbable, partially-threaded screw with a conical head and rounded bottom.
The WISORB™ has a single size with the following dimensions:
- i. Length 30 mm
- Thread diameter 4.5 mm ii.
- iii. Thread length 11.64 mm
- Shaft diameter 2.62 mm iv.
- Head diameter 6.75 mm v.
- Head depth 6.73 mm vi.
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