Who is the manufacturer of WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)?

Wrightmedicaltechnologyinc filed the 510(k) submission for WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) (K963587).

What is the FDA product code for WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)?

MQV. It is classified under 21 CFR 888.3045 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)

K963587 · Wrightmedicaltechnologyinc · MQV · Mar 24, 1997 · Orthopedic

Device Facts

Record ID	K963587
Device Name	WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
Applicant	Wrightmedicaltechnologyinc
Product Code	MQV · Orthopedic
Decision Date	Mar 24, 1997
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 voids in long bone. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

Kit contains calcium sulfate powder and saline; mixed in provided bowl; shaped in provided mold to form pellets. Used by surgeons to fill non-loadbearing bone voids; pellets resorb in 30-60 days; replaced by natural bone during healing. Sterile, single-patient use.

Clinical Evidence

Bench testing only. Dissolution studies confirm equivalent rates to predicate. Mechanical testing confirms compressive failure rate equivalent to predicate and trabecular bone. Mass/volume ratio within 15% of predicate. Non-pyrogenic verification performed.

Technological Characteristics

Calcium sulfate (plaster of Paris) bone void filler. Kit includes powder, saline, mixing bowl, and mold. Sterile, single-use. Radiopaque. Resorbable.

Indications for Use

Indicated for patients with non-loadbearing osseous defects in long bone, resulting from surgical creation 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

Wright Plaster of Paris Pellets

Related Devices

K960978 — WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) · Wrightmedicaltechnologyinc · Jun 21, 1996
K010532 — OSTEOSET BVF KIT · Wrightmedicaltechnologyinc · Oct 26, 2001
K963562 — WRIGHT PLASTER OF PARIS PELLETS · Wrightmedicaltechnologyinc · May 7, 1997
K002362 — SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) · Synthes (Usa) · Nov 1, 2000
K072170 — WELLGRAFT PE II · Gwowei Technology Co., Ltd. · Apr 4, 2008

Submission Summary (Full Text)

{0} MAR-14-97 12:57 FROM:WRIGHT MEDICAL CR AFFAIRS ID: PAGE 5/5 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 K963587 Contact Person: Robert Churinetz Date Prepared: March 14, 1997 MAR 24 1997 ## 510(k) Summary | Trade/Proprietary Name: | Wright Plaster of Paris Bone Void Filler Kit | | --- | --- | | Common Name: | Calcium Sulfate | | Product Classification: | Unclassified | | Predicate Device: | Wright Plaster of Paris Pellets | 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 Bone Void Filler Kit contains calcium sulfate powder and saline in premeasured quantities, so that when mixed together in the mixing bown provided, then placed into the mold provided, the mixture sets to form Wright Plaster of Paris Pellets. The biodegradable, radiopaque pellets are resorbed in 30-60 days when used according to labeling. The kit is provided sterile for single patient use. Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing voids in long bone. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. ## Material When mixed according to directions, the kit produced calcium sulfate (plaster of Paris) pellets. ## Testing Summary Dissolution studies demonstrate Wright Plaster of Paris Bone Void Filler Kit to possess equivalent dissolution rates to the predicate device. Mechanical testing demonstrated the cast pellets have a compressive failure rate substantially equivalent to the compressed pellets and to trabecular bone. Testing indicates the cast pellets have a mass/volume ratio within 15% of the compresses pellets. Testing indicates the product to be non-pyrogenic following the calcining process.