(90 days)
The Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Synthes Hindfoot Arthrodesis Nail System is composed of titanium cannulated arthrodesis nails, 6.0 mm Locking Screws, and end caps. Synthes commercially available spiral blades, locking screws, and locking bolts are used to secure the nail in the bone, preventing rotation and axial compression.
I am sorry, but I am unable to answer your question. The provided text is a 510(k) summary for a medical device (Synthes Hindfoot Arthrodesis Nail System) and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study report detailing specific performance metrics or clinical trial results. Therefore, I cannot extract the requested information from the given context.
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SEP 2 1 2005
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Revised 510(k) Summary
K051678
사용
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| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
|---|---|
| Device Name: | Synthes Hindfoot Arthrodesis Nail System |
| Classification: | Class II, §888.3020 - Intramedullary Fixation Rod |
| Predicate Devices: | Biomet Inc. - Titanium Ankle Arthrodesis NailSynthes - 6.0 mm Locking Screws (accessory in Titanium DistalFemoral Nail System) |
| Device Description: | Synthes Hindfoot Arthrodesis Nail System is composed oftitanium cannulated arthrodesis nails, 6.0 mm Locking Screws,and end caps. Synthes commercially available spiral blades,locking screws, and locking bolts are used to secure the nail in thebone, preventing rotation and axial compression. |
| Intended Use: | Synthes Hindfoot Arthrodesis Nail System is intended to facilitatetibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity,arthritis, instability, and skeletal defects after tumor resection.These include, but are not limited to Neuro-osteoarthropathy(Charcot's Foot), Avascular Necrosis of the talus, failed jointreplacement, failed ankle fusion, distal tibia fracture non-unions,Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the SynthesHindfoot Arthrodesis Nail System to be substantially equivalent toother legally marketed devices. |
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SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Senior Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051678 . R051678
Trade/Device Name: Synthes (USA) Hindfoot Arthrodesis Nail System Regulation Name: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 21, 2005 Reccived: June 23, 2005
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the devices in We have reviewed your Section - 10(x) premaince netibiation worked in intentions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule to regary maneted povice Americal Device Ameral Hood Drug commerce prof to May 20, 1776, the enternets and the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval aranges of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls, provisions of You may, merelore, market the device, salger to we s
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the Floridae required required against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), If your device is classified (see a00%) into existing major regulations affecting your device. FDA il may be subject to such additional Controllar Bloghing Chile 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to can be found in the Code of Peachartegories concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence ectermination does not mean Please be advised that TDA s issuates of a stations with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decertimation that your cerced by other Federal agencies. You must a or iny recerdi statutes and regulations achinities or registration and listing (21)
comply with all the Act's requirements, including, but not issues seguirements as set comply with an the Act s requirements, memormalice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing phartice the electron CFR Part 807), labeling (21 CFR Part 820); and 11 applicable, the electronic form in the quality systems (Q5) roganations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 – Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k)
The Cases of the Cases of a first of a between of your device to a legally This letter will allow you to begin minketing your antinee of your device to a legally
premarket notification. The FDA finding of substantial equive and thus, permits your premarket notification. The FDA Inding of substantial of the survey of device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our nabing vegen note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the reg contact the Office of Compliance at (240) 276-01-07 Part 807.97). You may obtain
"Misbranding by reference to premarket notification in from 807.97). You may obtain "Misbranding by reference to premiset nothlication" (27 Of from the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-204 other general information on your responsionings and its foll-free mumber (800) 638-2041 or 1988)
Manufacturers, International and Consumer Assistance at its formations html Manufacturers, International and Consumer Assistance to to tor treating on the many of index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdch/industry/
Sincerely yours,
Z
for Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Synthes (USA) Hindfoot Arthrodesis Nail System
INDICATIONS FOR USE:
Device Name:
The Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051678
2.0
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.