← Product Code [MQV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV) · K963562 # WRIGHT PLASTER OF PARIS PELLETS (K963562) _Wrightmedicaltechnologyinc · MQV · May 7, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963562 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [MQV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV.md) - **Decision Date:** May 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3045 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963562](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963562) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com