(62 days)
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
o Replantations and reconstructions
o Arthrodeses of joints involving small bones
o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures
The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) consists of stainless steel and titanium plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. The plates and screws contained in the DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) are offered in a range of configurations to accommodate patient anatomy and surgical need. The subject system contains two plate and screw sizes, 1.3 mm and 2.0 mm, general instruments, and device specific instruments. The 1.3 mm plates in this submission are designed to accept new 1.3 mm cortex and locking screws. The 2.0 mm plates are designed to accept existing 2.0 mm cortex screws, 2.0 mm locking screws, and new 2.0 mm Variable Angle (VA) locking screws. The new 2.0 mm VA locking plates and screws feature existing variable angle locking technology (K100776).
This document is a 510(k) premarket notification for the DePuy Synthes Variable Angle Locking Hand System. It is a submission to the FDA for a medical device, which means it describes the device and its intended use, but it does not contain information about an AI/ML-driven device or study results of the type you're asking for.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. This document pertains to a physical medical implant (plates and screws for hand fracture fixation).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Synthes (USA) Products, LLC Mr. Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K150099
Trade/Device Name: DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 16, 2015 Received: January 20, 2015
Dear Mr. Fountoulakis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 - Mr. Nicholas Fountoulakis
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws)
Indications for Use (Describe)
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
- o Replantations and reconstructions
- o Arthrodeses of joints involving small bones
- o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared: March 13, 2015
| Sponsor: | DePuy SynthesNicholas S. Fountoulakis1301 Goshen ParkwayWest Chester, PA 19380Office: (610) 719-6553Fax: (484) 356-9682 |
|---|---|
| ProprietaryName: | DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Platesand Screws) |
| Classification: | Class II, HRS, §888.3030 – Plate, Fixation, BoneClass II, HWC, §888.3040 - Screw, Fixation, Bone |
| PrimaryPredicateDevices | K030310 – Synthes Stainless Steel Modular Hand System |
| AdditionalPredicateDevices | K063049 – Synthes (USA) Modular Mini Fragment LCP SystemK100776 - Synthes 2.4 mm/2.7 mm Variable Angle LCP Forefoot/Midfoot SystemK112583 - Synthes Cortical Screws |
| DeviceDescription: | The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mmPlates and Screws) consists of stainless steel and titanium plates and screws thatoffer screw-to-plate locking designed for various fracture modes of the hand. Theplates and screws contained in the DePuy Synthes Variable Angle Locking HandSystem (1.3 mm and 2.0 mm Plates and Screws) are offered in a range ofconfigurations to accommodate patient anatomy and surgical need. The subjectsystem contains two plate and screw sizes, 1.3 mm and 2.0 mm, general instruments,and device specific instruments. The 1.3 mm plates in this submission are designedto accept new 1.3 mm cortex and locking screws. The 2.0 mm plates are designed toaccept existing 2.0 mm cortex screws, 2.0 mm locking screws, and new 2.0 mmVariable Angle (VA) locking screws. The new 2.0 mm VA locking plates and screwsfeature existing variable angle locking technology (K100776). |
| Indications forUse: | The DePuy Synthes Variable Angle Locking Hand System is intended for fracturefixation of the hand and other small bones and small bone fragments, in adults andadolescents (12-21) particularly in osteopenic bone.System indications include the following:Open reduction and internal fixation of fractures, mal-unions, and non-unions Following excision of benign bone tumors Replantations and reconstructions Arthrodeses of joints involving small bones Osteotomies, including deformity correction such as rotation, lengthening, shortening Pathological fractures, including impending pathologic fractures |
| SubstantialEquivalence: | The proposed DePuy Synthes Variable Angle (VA) Locking Hand System (1.3 mmand 2.0 mm Plates and Screws) shares the same fundamental technologicalcharacteristics and intended use as the predicate Synthes systems (K030310,K112583, K063049, K100776). Fatigue strength testing was completed for theplates included in the subject system, demonstrating equal or greater strength incomparison to representative predicate plates. Plates were setup for fatigue strengthtesting in a plate-screw construct configuration that was intended to target theweakest portion of the plate by aligning the simulated fracture gap with the plate'ssmallest cross sectional area. New 1.3 mm Cortex and Locking Screws and 2.0 mmVA Locking Screws were tested using methods detailed in ASTM F543-13 in orderto demonstrate performance in accordance with the specifications of the standard orin cases where a benchmark specification was not available, comparison was made torepresentative predicate devices. Literature has been provided to support the revisionin indications, most notably the addition of the adolescent population Lastly,technological characteristics of the DePuy Synthes Variable Angle System such aslocking holes, limited contact profiles, variable and standard locking technology,anatomic contours, and size ranges are prominent throughout the representativepredicate systems. Based on the similarity of technical features across the predicatedevice, results of the performance data, and literature discussions, the subject DePuySynthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates andScrews) is substantially equivalent to the predicate devices. |
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.