← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K964215 # ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM (K964215) _Smith & Nephew Endoscopy, Inc. · HRX · Dec 20, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K964215 ## Device Facts - **Applicant:** Smith & Nephew Endoscopy, Inc. - **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md) - **Decision Date:** Dec 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.1100 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects. ## Device Story MosaicPlasty Comprehensive System is a kit of manual orthopedic surgical instruments used for osteochondral grafting. Components include drill guides, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressors, and adapters. Used in knee and ankle arthroscopic or open procedures by orthopedic surgeons. Instruments facilitate harvesting bone grafts, preparing recipient sites, and transferring/tamping grafts into defects. Stainless steel construction. No electronic or software components. ## Clinical Evidence No clinical data provided; bench testing and comparison to legally marketed predicate devices used to establish safety and effectiveness. ## Technological Characteristics Manual orthopedic surgical instruments. Materials: Stainless steel. Dimensions: 2.7 mm to 10 mm diameter. Includes drill guides, bits, chisels, trephines, tamps, transfer tubes, and compressors. Sterilization: Sterilizing tray included. No energy source, connectivity, or software. ## Regulatory Identification An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. ## Predicate Devices - Drill Guide (Synthes®) - Drill Bits (Synthes®) - Gouges (Synthes®) - Trephine Drills (Smith & Nephew Endoscopy) - Tamps (Zimmer®) - Bone Grafter (Instrument Makar®) - Bone Compression Forceps (KMedic®) ## 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} DEC 20 1996 K964215 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K964215 This summary was prepared on December 16, 1996 ## A. Submitter Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, MA 02048 Establishment Registration Number: 1219602 ## B. Company Contact Tedd Gosian Clinical / Regulatory Manager ## C. Device Name Trade Name: Acufex® MosaicPlasty™ Comprehensive System Common Name: Drill Bits, Chisels, Trephines, Tamps, Drill Guide, Compression Instrument Classification Name: Orthopedic Manual Surgical Instruments, Template Surgical Instruments Motors Accessories ## D. Predicate/Legally Marketed Devices All of the components in the MosaicPlasty Comprehensive System are Class I Exempt Devices, except drill bits and adapters which are Class I. Predicate/Legally Marketed Devices include: - Drill Guide: Synthes® - Drill Bits: Synthes® - Gouges: Synthes® - Trephine Drills: Smith & Nephew Endoscopy - Tamps: Zimmer® - Bone Grafter: Instrument Makar® - Bone Compression Forceps: KMedic® {1} # E. Device Description The MosaicPlasty Comprehensive System is a kit composed of several orthopedic manual surgical instruments. These instruments include drill guides, drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 10 mm. # F. Indications For Use The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects. # G. Substantial Equivalence The components of the MosaicPlasty Comprehensive System are Class I exempt devices, except drill bits and adapters which are Class I. The components are similar in design, function, materials and intended use as other devices currently in commercial distribution. All devices are composed of stainless steel. The intended use and commercially available devices are presented in the table below. Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations. | Intended Use | Current Product MosaicPlasty Comprehensive System Components | Substantially Equivalent Product | | --- | --- | --- | | Drill Template | Drill Guide Arthroscopic Drill Guide | Drill Guide (Synthes®) | | Use with Template | Drill Plugs Graft Template | Drill Sleeves (Synthes) | | Drilling in Bone | 2.4 mm Pilot Drill Bit 2.7 mm Arthr. Drill Arthr. Reamer Drills Drill Bits | Drill Bits (Synthes) | | Harvesting Bone Grafts | Tubular Chisels | Gouges (Synthes) | | Cutting circular bone section | Trephines | Trephine Drills (Smith & Nephew Endoscopy) | | Tamping Graft into site | Tamps Transfer Plunger Sculpture Stick | Tamps (Zimmer®) | | Transferring bone graft to recipient site | Transfer Tubes Arthr. Transfer Tubes Chisel Collar | Bone Grafter (Instrument Makar®) | {2} | Adapting drill bit or trephine to orthopedic drill | Trephine Adapters (Quick Coupling, Power) | Quick Coupling Adapter (Synthes) | | --- | --- | --- | | Compress bone block | Bone Plug Compressor | Bone Compression Forceps (KMedic®) | | For instrument access into joint | Metal Cannula | Metal Cannula (Smith & Nephew Endoscopy) | Applicant Todd J. Brown Date 12/17/96 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K964215](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K964215) **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. 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