← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K091609 # NEWDEAL COMPRESSION PLATE (K091609) _Newdeal Sas · HRS · Jun 30, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K091609 ## Device Facts - **Applicant:** Newdeal Sas - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Jun 30, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery . - Fracture management in the foot or hand . - . Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies . - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc) ● The size and number of the plate(s) used should be adapted to the specific indication. ## Device Story Metallic bone fixation plate; utilizes diamond-shaped 'eye' opening to provide compression between bone fragments via mechanical deformation; rigidity maintained by locking system consisting of screw and washer. Used by orthopedic surgeons in clinical settings for hand and foot surgeries. Provides stable fixation for fractures and osteotomies; facilitates bone fusion. Output is physical stabilization of bone segments. ## Clinical Evidence Bench testing only. Mechanical properties of the modified plate were compared to the predicate device (K070447) to demonstrate equivalence. ## Technological Characteristics Metallic bone fixation plate; features diamond-shaped 'eye' for compression and screw/washer locking system. Dimensions and number of plates adapted to specific surgical indications. ## Regulatory 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. ## Predicate Devices - Newdeal Compression Plate ([K070447](/device/K070447.md)) - UNI-CLIP ([K011716](/device/K011716.md)) - Newdeal Large UNI-CLIP ([K061594](/device/K061594.md)) - Surfix Knee Osteotomy System ([K041601](/device/K041601.md)) - Newdeal Lisfranc Plates ([K060474](/device/K060474.md)) - Newdeal Lapidus Plates ([K060476](/device/K060476.md)) - Newdeal TTC Plates ([K060473](/device/K060473.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 2091609 Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black letters, with a registered trademark symbol to the right of the word. To the left of the word is a circular design with three dots along the circle's edge. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, italicized font. # 510(K) SUMMARY JUN 3 0 2009 ## Newdeal Compression Plate Submitter's name and address: Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - FRANCE Tel: +33.4.37.47.51.51 Fax: +33.4.37.47.51.52 ## Contact person and telephone number Marilyse Latour Manager of Regulatory Affairs Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - 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: May 28, 2009 ## Name of the device: | Proprietary Name: | Newdeal Compression 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 | {1}------------------------------------------------ ## Substantial Equivalence: The modified Newdeal Compression Plate is substantially equivalent to commercially marketed device, Newdeal Compression Plate, K070447. ## Device Description: The Newdeal Compression Plate will offer the combination of two concepts: - By widening the "eye" (diamond shaped opening) on the interaxis of the plate, . mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the Newdeal Compression Plate (K070447), UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594). - The rigidity of the "legs" is obtained using the Newdeal Locking System including a ● screw and a washer. This is the same principle as the Locking System of the following predicate devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447). #### Intended Use: The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction. #### Examples include: - Arthrodesis in hand or foot surgery . - Fracture management in the foot or hand . - Mono or Bi-cortical osteotomies in the foot or hand . - Distal or proximal metatarsal or metacarpal ostcotomies ● - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf. Chevron, etc) ● The size and number of the plate(s) used should be adapted to the specific indication. #### Testing and Test Results: Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plate are equivalent to the properties of the unmodified device, Newdeal Compression Plate, K070447. #### Conclusion The modified Newdeal Compression Plate is substantially equivalent to commercially marketed device, Newdeal Compression Plate, K070447. 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. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, representing the department's mission related to health and human welfare. The logo is presented in black and white. Public Health Service JUN 30 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Newdeal SAS % Ms. Judith E. O'Grady 311 Enterprise Drive Plainsboro, New Jersey 08536 Re: K091609 Trade/Device Name: Newdeal Compression 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 28, 2009 Received: June 03, 3009 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 (OS) 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 E. 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, Barbara Buchun for 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): Kog) b()9 Device Name: Newdeal Compression Plate Indications For Use: The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery � - Fracture management in the foot or hand . - . Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies . - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc) ● The size and number of the plate(s) used should be adapted to the specific indication. 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) Souther (Division Sign Off) Division of Surgical, Orthopedic, A Restorative Devices Number K091609 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K091609](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K091609) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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