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

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.

AI/ML Overview

The provided text describes a medical device, the "Newdeal HALLU® Lock Plate System," which is a bone fixation appliance. It is a 510(k) summary, indicating that it aims to demonstrate substantial equivalence to an existing device rather than presenting entirely new clinical trial data for novel acceptance criteria.

Therefore, the structure of the response will reflect the information available in a 510(k) summary for a substantially equivalent device, focusing on mechanical testing rather than extensive clinical studies.

Here's the information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to Predicate Device (HALLU® Plate System, K021626)	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.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes mechanical testing, not a clinical study involving human subjects or data related to patient outcomes. Therefore, information regarding "sample size used for the test set" in the context of clinical data, "data provenance (e.g. country of origin of the data, retrospective or prospective)," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth (e.g., pathology, outcomes data)," "training set sample size," and "how ground truth for training set was established" are not applicable to this type of submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable (as per explanation in point 2). The ground truth for mechanical testing is typically based on established biomechanical standards and measurements, not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable (as per explanation in point 2).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bone fixation plate, and the submission focuses on mechanical equivalence. An MRMC study is relevant for diagnostic imaging AI, which is not the subject here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing performed, the ground truth would be established through objective physical measurements and engineering analyses under controlled laboratory conditions, demonstrating that the new device's mechanical properties (e.g., strength, stiffness, fatigue resistance) fall within acceptable predefined limits or are equivalent to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable (as per explanation in point 8).

Summary

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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

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Substantial Equivalence:

The modified HALLU® Lock Plate System is substantially equivalent to commercially marketed device, HALLU® Plate System, K021626

Device Description:

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

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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.

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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

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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

Regulation Number and Section

§ 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.