(83 days)
Not Found
No
The description focuses on the mechanical design and intended use of a bone plate and screw system, with no mention of AI or ML capabilities.
Yes.
The device is intended for bone fixation and stabilization, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is an osteosynthesis plate used for bone fixation and stabilization, not for diagnosing conditions.
No
The device description clearly outlines physical components (osteosynthesis plate, screws, washers) that are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (bone plates and screws) used for bone fixation during surgical procedures on the foot. It is implanted directly into the body to stabilize bones.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is purely mechanical and structural within the body.
Therefore, based on the provided information, the NEWDEAL Lapidus Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:
- arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
- Lisfranc arthrodesis -
- mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
Product codes
HRS
Device Description
The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st tarsometatarsal joint, 1st metatarsocuneiform 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)
An evaluation of the bending resistance based upon mechanical calculations has demonstrated that the bending behavior of the Lapidus Plates will be greater than predicate devices (Synthes Modular Foot System).
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
Newdeal SAS 510(k): PreMarket Notification Lapidus Plates
MY 17 -
Image /page/0/Picture/2 description: The image contains the word "CONFIDENTIAL" in bold, uppercase letters. Above the word "CONFIDENTIAL" is the alphanumeric string "K060476" in a handwritten style. The text is black against a white background.
V. 510(K) SUMMARY
Lapidus Plates
Submitter's name and address:
Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
Contact person and telephone number
Morgane Grenier Regulatory and Clinical Affairs Director Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
Alternate Contacts
Authorized Agent in the United States
Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: (609) 936-2311 Fax: (609) 275-9445 E-mail: jogrady@integra-ls.com
Date Summary was prepared:
February 20, 2006
Name of the device:
| Proprietary Name: | Lapidus Plate |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (21CFR 888.3030) | |
| Device Product Code: | HRS |
| Classification Panel: | Orthopedic |
Substantial Equivalence:
The Lapidus Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.
1
Newdeal SAS 510(k): PreMarket Notification Lapidus Plates
CONFIDENTIAL
KOREATA
Device Description:
The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
Intended Use:
The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:
- arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
- Lisfranc arthrodesis -
- Mono or bi-cortical osteotomies or fractures near the 1* metatarsocuneiform joint. -
Testing and Test Results:
An evaluation of the bending resistance based upon mechanical calculations has demonstrated that the bending behavior of the Lapidus Plates will be greater than predicate devices (Synthes Modular Foot System).
Conclusion
The Newdeal Lapidus Plates are substantially equivalent to commercially marketed devices, the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.
The Newdeal Lapidus Plates do not raise any new issues of scientific technology, safety or effectiveness.
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures connected by flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Newdeal SA c/o Ms. Judith O'Grady, R.N., M.S.N. Sr. VP. Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K060476
Trade/Device Name: Lapidus Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 10, 2006 Received: May 11, 2006
Dear Ms. O'Grady:
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
3
Page 2 - Ms. Judith O'Grady, R.N., M.S.N.
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. 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 Semer ws
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
IV. Indications for Use
510(k) Number (if known):
Device Name: Lapidus Plates
Indications For Use:
The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:
- arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
- Lisfranc arthrodesis -
- mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint. ﺳ
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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)
Herbert Lerner no
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060476
I
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