WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)

K960978 · Wrightmedicaltechnologyinc · MQV · Jun 21, 1996 · Orthopedic

Device Facts

• Record ID: K960978
• Device Name: WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the healing process.

Device Story

Biodegradable, radiopaque calcium sulfate dihydrate pellets; used as bone void filler; packed into non-loadbearing long bone defects; resorbed in 30-60 days; replaced by bone during healing; sterile, single-patient use; 0.1g per pellet; supplied in 100-count pouches.

Clinical Evidence

Bench testing only; dissolution studies demonstrate equivalent dissolution rates to predicate device.

Technological Characteristics

Composition: 98% medical grade calcium dihydrate (CaSO4 • 2H2O), 2% stearic acid; form factor: 0.1g pellets; sterile; biodegradable; radiopaque.

Indications for Use

Indicated for filling non-loadbearing long bone voids resulting from surgical procedures or traumatic injury.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Plaster of Paris Pellets (Ethicon)

Submission Summary (Full Text)

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JUN 21 1996
K960978

WRIGHT
MEDICAL TECHNOLOGY, INC.
5677 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971

Contact Person: Robert Churinetz
Date Prepared: June 6, 1996

510(k) Summary of Safety and Efficacy

Trade/Proprietary Name: Wright Plaster of Paris Pellets
Common Name: Calcium Sulfate Dihydrate
Product Classification: Unclassified
Predicate Devices: Plaster of Paris Pellets (Ethicon)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Description/Intended Use
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in 30 to 60 days when used according to labeling. Wright Plaster of Paris Pellets are 0.1g each and are supplied in pouches of 100 pellets.

Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the healing process.

Material
Wright Plaster of Paris Pellets are made of 98% medical grade calcium dihydrate (CaSO₄ • 2H₂O) and 2% stearic acid.

Testing Summary
Dissolution studies demonstrate Wright Plaster of Paris Pellets to possess equivalent dissolution rates to the predicate device.