(259 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic plate system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an orthopedic implant (plate and screws) intended for fixation of fractures, osteotomies, or arthrodesis, which is a structural support device rather than a therapeutic one. Its purpose is mechanical stabilization, not active treatment or mitigation of a disease.
No
Explanation: The device is a plate intended for fixation of fractures and similar conditions in the first metatarso-phalangeal joint, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly states it is a "low profile Titanium plate" and mentions "screws and lock-screws" for fixation, indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint." This describes a surgical implant used to physically stabilize bone structures.
- Device Description: The description details a "low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The HALLU® Lock Plate System is intended to be implanted for fixation of fractures, osteotomies or arthordesis of the first metatarso-phalangeal joint, including cases of :
- Hallux rigidus
- Severe hallux valgus (IM angle >20° and HV angle > 40°) -
- Deformity from rheumatoid arthritis -
- Failed previous surgical procedure -
- Traumatic arthritis -
- -Neuromuscular instability.
Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
HALLU® Lock Newdeal® plates must be fixed with the Surfix® fixed angle locking system and with the Surfix® -Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarso-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)
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified HALLU® Lock Plate System are equivalent to the properties of the unmodified device, HALLU® Plates, K021626.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K083154 1/2
Image /page/0/Picture/1 description: The image shows the logo for "newdeal", which is written in a stylized font. To the left of the word is a circle with four dots around it. Below the word "newdeal" is the text "An Integra LifeSciences Company".
510(K) SUMMARY
Newdeal HALLU® Lock Plate System
JUL 1,0 2009
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 Director of Regulatory and Clinical Affairs - EMEA 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:
July 7, 2009
Name of the device:
| Proprietary Name: | Newdeal HALLU® Lock Plate System |
|---|---|
| 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 |
1
Substantial Equivalence:
The modified HALLU® Lock Plate System is substantially equivalent to commercially marketed device, HALLU® Plate System, K021626
Device Description:
The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.
Intended Use:
The HALLU® Lock Plate System is intended to be implanted for fixation of fractures, osteotomies or arthordesis of the first metatarso-phalangeal joint, including cases of :
- Hallux rigidus
- Severe hallux valgus (IM angle >20° and HV angle > 40°) -
- Deformity from rheumatoid arthritis -
- Failed previous surgical procedure -
- Traumatic arthritis -
- -Neuromuscular instability.
Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
HALLU® Lock Newdeal® plates must be fixed with the Surfix® fixed angle locking system and with the Surfix® -Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
Testing and Test Results:
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified HALLU® Lock Plate System are equivalent to the properties of the unmodified device, HALLU® Plates, K021626.
Conclusion
The modified HALLU® Lock Plate System is substantially equivalent to commercially marketed device, HALLU® Plates, K021626.
The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
KOR 3124
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS % Ms. Judith O'Grady Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
1.0 2009
Re: K083154
Trade/Device Name: HALLU Lock Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC
Dated: June 10, 2009 Received: June 11, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Judith O'Grady
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Halvare Queim
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 083 | 54
Device Name: HALLU® Lock Plates
Indications For Use:
The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:
- Hallux rigidus -
- Severe hallux valgus (IM angle >20° and HV angle >40°) -
- Deformity from rheumatoid arthritis -
- Failed previous surgical procedure -
- Traumatic arthritis
- Neuromuscular instability.
The HALLU® Lock plates must be fixed with the SURFIX® fixed angle locking system and with the SURFTX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kuta
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number
Attachment B1 - Page 1 of 1