(66 days)
Not Found
No
The 510(k) summary describes a physical implant (a staple) for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
This device is an implantable staple for bone fixation, used in osteotomies and arthrodesis of the foot. It is a structural implant for mechanical stabilization, not a device that provides therapy or treatment.
No
The device is described as an implantable bone fixation appliance, specifically a staple, used for orthopedic procedures like osteotomies and arthrodesis. It is intended for fixation, not for diagnosing a condition or disease.
No
The device description clearly states it is a "single-use, bone fixation appliance intended to be implanted in the foot" and is "manufactured from a Nickel-Titanium alloy," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of the foot through the implantation of staples. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a bone fixation appliance intended to be implanted. This confirms it's an implantable medical device used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
Therefore, the Memory 12 and Memory 20 staples are implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
JDR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, first phalanx of the foot, first metatarsal phalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Drive
Warsaw, Indiana 46581-0988
Establishment Registration Number: 1818910 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs
Telephone: (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.
1
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.
2
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.
3
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