Who is the manufacturer of WRIGHT PLASTER OF PARIS PELLETS?

Wrightmedicaltechnologyinc filed the 510(k) submission for WRIGHT PLASTER OF PARIS PELLETS (K963562).

What is the FDA product code for WRIGHT PLASTER OF PARIS PELLETS?

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 PELLETS?

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

Who can help prepare an FDA 510(k) submission like WRIGHT PLASTER OF PARIS PELLETS?

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 PELLETS

Q: What are the predicate devices for WRIGHT PLASTER OF PARIS PELLETS?

Plaster of Paris Pellets (Ethicon).

K963562 · Wrightmedicaltechnologyinc · MQV · May 7, 1997 · Orthopedic

Device Facts

Record ID	K963562
Device Name	WRIGHT PLASTER OF PARIS PELLETS
Applicant	Wrightmedicaltechnologyinc
Product Code	MQV · Orthopedic
Decision Date	May 7, 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 indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects 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. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.

Device Story

Wright Plaster of Paris Pellets; sterile, single-use, biodegradable, radiopaque bone void filler. Composed of medical-grade calcium sulfate and stearic acid. Intended for surgical implantation into non-structural bony voids or gaps in extremities, spine, or pelvis. Pellets resorb in 30-60 days, replaced by natural bone during healing. Biocompatible nature allows use in infected sites. Physician-operated during orthopedic procedures.

Clinical Evidence

No clinical data submitted; substantial equivalence based on identical technological characteristics to predicate.

Technological Characteristics

Material: medical grade calcium sulfate and stearic acid (tableting aid). Form factor: pellets. Biodegradable; radiopaque. Sterilization: provided sterile.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability; applicable to surgically created or traumatic osseous defects; suitable for use at infected sites.

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)

Related Devices

K960978 — WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) · Wrightmedicaltechnologyinc · Jun 21, 1996
K002362 — SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) · Synthes (Usa) · Nov 1, 2000
K010532 — OSTEOSET BVF KIT · Wrightmedicaltechnologyinc · Oct 26, 2001
K072170 — WELLGRAFT PE II · Gwowei Technology Co., Ltd. · Apr 4, 2008
K982663 — STIMULAN- CALCIUM SULFATE BONE VOID FILLER · Encore Orthopedics, Inc. · Feb 26, 1999

Submission Summary (Full Text)

{0} SENT BY:ADMIN 1ST FL. : 5-6-97 : 1:19PM WRIGHT VED CAL. 301 594 2358 # 6/6 MAY - 7 1997 K963562 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. (a) (1) Submitter's name: Wright Medical Technology, Inc. Submitter's address: 5677 Airline Road, Arlington, Tennessee 38002 Submitter's telephone number: 901/867-9971 Contact person: Robert Churinetz Date summary prepared: May 6, 1997 (2) Trade or proprietary device name: Wright Plaster of Paris Pellets Common or usual name: Calcium sulfate Classification name: Unknown (3) Legally marketed predicate device: Plaster of Paris Pellets (Ethicon) (4) Subject device description: Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used according to labeling. Wright Plaster of Paris Pellets are made of medical grade calcium sulfate and stearic acid (as a tableting aid). (5) Subject device intended use: Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects 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. Because the pellets are biodegradable and biocompatible, they may be used at an infected site. (6) Technological characteristics: The new device and the predicate device as described in (a) (3) are identical. In summary, the subject device has the same technological characteristics (i.e., design, material, and chemical composition) when compared to the predicate device. (b) Performance data Since a determination of substantial equivalence was not based on an assessment of performance data, no performance data was submitted.