← Product Code [MQV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV) · K963587 # WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) (K963587) _Wrightmedicaltechnologyinc · MQV · Mar 24, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963587 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [MQV](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV.md) - **Decision Date:** Mar 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3045 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## 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 - Wright Plaster of Paris Pellets ## 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} 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963587](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQV/K963587) **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