(66 days)
Memory 12 and Memory 20 staples are implants intended for fixation of the foot.
Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.
The patient's anatomy and skeleton must be capable of receiving the selected implant.
The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.
The provided text is a 510(k) Summary for a medical device called the "Memory™ Staple." It details the device's description, intended use, indications for use, and a statement of substantial equivalence to a predicate device.
However, the document does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria. This type of information would typically be found in a performance data section, which is absent from this summary.
Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) because the provided text does not contain any of this information.
The document primarily focuses on establishing substantial equivalence to a previously cleared device (DePuy Memory Staple, K964226) based on similarities in intended use, indications for use, materials, and design. This suggests that the regulatory submission relied on the established safety and effectiveness of the predicate device rather than presenting new clinical or performance study data for the new device itself.
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K0607 46
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
MAY 2 5 2006
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration Number: 1818910 |
|---|---|
| 510(K) CONTACT: | Rhonda MyerRegulatory AffairsTelephone: (574) 371-4927 |
DATE PREPARED:
February 23, 2006
Memory™ Staple
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICES:
Bone Fixation Staple
Class II device per 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener 87 JDR
DePuy Memory Staple (Size 12), K964226, cleared on August 5, 1997
DEVICE DESCRIPTION:
The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.
INTENDED USE AND INDICATIONS:
Intended Use:
The Memory Staple is intended to be implanted for bone fixation in the foot.
Indications for Use:
Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.
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BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the DePuy Memory Staple is substantiated by its similarity in intended use, indications for use, materials and design to the existing DePly Memory Staple, cleared in K964226, on August 5, 1997.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
DePuy Orthopaedics, Inc % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K060746
Trade/Device Name: Memory™ Staple Regulation Number: CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDR Dated: March 17, 2006 Received: March 20, 2006
Dear Ms. Myer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Rhonda Myer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lehman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is the text "a Johnson-Johnson company" in a smaller, cursive font.
DePuy Orthopaedics, Inc.
PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA
Tel: +1 (574) 267 8143
Indications for Use Statement
1000746
510 (k) Number (if known):
Device Name:
Indications for Use:
Memory 12 and Memory 20 staples are implants intended for fixation of the foot.
Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.
The patient's anatomy and skeleton must be capable of receiving the selected implant.
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Prescription Use:
Over-The-Counter-Use: OR
(Please do not write below this line - continue on another page if necessary)
Herbert Penner
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Num
§ 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.