(59 days)
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
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.
This 510(k) summary describes a surgical instrument system and, as such, does not contain the information required to answer your request. The provided text focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use for regulatory clearance, rather than presenting clinical study data with acceptance criteria and performance metrics typically associated with algorithms or diagnostic devices.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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DEC 2 0 1996
/5964/215
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, TemplateSurgical Instruments Motors Accessories |
Predicate/Legally Marketed Devices D.
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® |
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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 ProductMosaicPlasty ComprehensiveSystem Components | Substantially Equivalent Product |
|---|---|---|
| Drill Template | Drill GuideArthroscopic Drill Guide | Drill Guide(Synthes®) |
| Use with Template | Drill PlugsGraft Template | Drill Sleeves(Synthes) |
| Drilling in Bone | 2.4 mm Pilot Drill Bit2.7 mm Arthr. DrillArthr. Reamer DrillsDrill Bits | Drill Bits(Synthes) |
| Harvesting Bone Grafts | Tubular Chisels | Gouges(Synthes) |
| Cutting circular bonesection | Trephines | Trephine Drills(Smith & Nephew Endoscopy) |
| Tamping Graft into site | TampsTransfer PlungerSculpture Stick | Tamps (Zimmer®) |
| Transferring bone graft torecipient site | Transfer TubesArthr. Transfer TubesChisel Collar | Bone Grafter(Instrument Makar®) |
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| Adapting drill bit ortrephine 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 intojoint | Metal Cannula | Metal Cannula(Smith & Nephew Endoscopy) |
Applicant
Tedh L. Sozan
Date 12/17/96
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.