Who is the manufacturer of CLAVICLE LOCKING PLATE SYSTEM?

Newclip Technics filed the 510(k) submission for CLAVICLE LOCKING PLATE SYSTEM (K100944).

What is the FDA product code for CLAVICLE LOCKING PLATE SYSTEM?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for CLAVICLE LOCKING PLATE SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CLAVICLE LOCKING PLATE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CLAVICLE LOCKING PLATE SYSTEM

K100944 · Newclip Technics · HRS · Oct 22, 2010 · Orthopedic

Device Facts

Record ID	K100944
Device Name	CLAVICLE LOCKING PLATE SYSTEM
Applicant	Newclip Technics
Product Code	HRS · Orthopedic
Decision Date	Oct 22, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The implants of the Newclip Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

Device Story

Clavicle Locking Plating System consists of titanium alloy plates and screws designed for surgical fixation of clavicle fractures, mal-unions, non-unions, and osteotomies. Implants feature anatomic, pre-contoured designs for midshaft and distal clavicle applications. System utilizes combination of locking and non-locking screws to provide mechanical stability. Provided non-sterile; requires steam sterilization by healthcare professionals prior to use. Used in clinical/surgical settings by orthopedic surgeons to stabilize bone segments, promoting healing and restoring structural integrity of the clavicle.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing, including comparative bending tests (ASTM F 382-99 Annex A1), fatigue tests (ASTM F 382-99 Annex A2), and torsional/pullout tests (ASTM F543-07 Annex A1/A3).

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F 136-02a/ISO 5832-3). Design: Anatomic, pre-contoured plates for midshaft and distal clavicle. Fixation: Combination of locking and non-locking screws. Surface: Color anodized. Sterilization: Steam sterilization by user.

Indications for Use

Indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle in patients requiring surgical stabilization.

Regulatory Classification

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

Locking Clavicle Plates System of the Congruent Bone Plate System of Acumed, Inc. (K012655)
Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew, Inc. (K061352)
3.5mm LCP Clavicle Plate System of Synthes (K073186)
Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852)

Related Devices

K103513 — LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA · Advanced Orthopaedic Solutions, Inc. · Oct 24, 2011
K254288 — Clavicle Fixation System · Skeletal Dynamics, Inc. · Mar 23, 2026
K073186 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM · Synthes (Usa) · Dec 17, 2007
K230805 — TriMed Clavicle Fixation System · TriMed, Inc. · Sep 1, 2023
K102095 — SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM · Suspension Orthopaedic Solutions, LLC · Dec 7, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, the word "TECHNICS" is in smaller, gray letters. Above the word "NEWCLIP" is a curved line that resembles a clip. K100944 OCT 22 2010 # 510 (k) Summary for the Newclip Clavicle Locking Plating System In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Newclip Clavicle Locking Plating System. Summary preparation date: September 15, 2010 #### 1. Submitter: ### Contact Person: | NEWCLIP TECHNICS Z.A du Pâtis Rue de la Fontaine Grillée F-44 690 La Haye-Fouassière - France Telephone: (33) 2 28 21 37 12 | J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199 | |-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| - Newclip Clavicle Locking Plating 2. Trade name: System Medial Clavicle Plates and screws Lateral Clavicle Plates and screws Common Name: Classification Name: Plate, Fixation, Bone (21 CFR part. 888.3030) Screw, Fixation, Bone (21 CFR part. 888.3040) #### Predicate or legally marketed devices which are substantially equivalent: 3. - The Locking Clavicle Plates System of the Congruent Bone Plate System of . Acumed, Inc. (K012655), - The Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating . System for the Upper Extremity of Smith & Nephew; Inc. (K061352), - The 3.5mm LCP Clavicle Plate System of Synthes (K073186), . - The Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852). {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is written in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" written in smaller, gray letters. Above the word "NEWCLIP" is a black semi-circle. | 4. Description of the device: | The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use. | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials: | Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-02a and/or ISO 5832-3). | | Function: | The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. | # 5. Substantial equivalence claimed to predicate devices: The Clavicle Locking Plating System is substantially equivalent to the Locking Clavicle Plates System of the Congruent Bone Plate System of Acumed, Inc. (K012655), the Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew; Inc. (K061352), the 3.5mm LCP Clavicle Plate System of Synthes (K073186) and the Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852) in terms of intended use, design, materials used, mechanical safety and performance. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above and to the right of the word "NEWCLIP" is a curved line that resembles a sunrise. The table below compares the features and characteristics of the Newclip Clavicle Locking Plating System to these predicate devices: | Sponsor | NEWCLIP TECHNICS S.A.S. | I.T.S. | ACUMED, INC. | SYNTHES | SMITH & NEPHEW, INC. | |----------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Newclip Clavicle Locking Plating System | Claviculaplate with Angular Stability System | Congruent Bone Plate System Clavicle Locking Plates | 3.5 mm LCP Clavicle Plate System | Peri-Loc Periarticular Locked Plating System Clavicle Locking Plates | | 510(K) Number | K100994 | K050852 | K012655 | K073186 | K061352 | | Regulatory Class | II | II | II | II | II | | Device Classification Name | Plate, Fixation, Bone | Plate, Fixation, Bone | Plate, Fixation, Bone | Plate, Fixation, Bone | Plate, Fixation, Bone | | Product Code | HRS | HRS | HRS | HRS | HRS | | Panel Code | 888.3030 | 888.3030 | 888.3030 | 888.3030 | 888.3030 | | Intended use | | | | | | | Indications for Use | Fixation of fractures, mal- unions, non- unions, and osteotomies of the clavicle. | Metaphysial and diaphyseal fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Corrective osteotomy and open and closed fractures. | Fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula. | Fixation of fractures, mal- unions, non- unions, and osteotomies of the clavicle. | Fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, and pelvic, osteotomies of acetabulum, metacarpal, humerus, ulna, radius, calcaneus and clavicle. | | Plates design | | | | | | | o Design | Anatomic contour Pre-contoured | Anatomic contour Pre-contoured | Anatomic contour Pre-contoured | Anatomic contour Pre-contoured | Anatomic contour Pre-contoured | | Devices | | | | | | | o Midshaft Clavicle plates | Yes | Yes | Yes | Yes | Yes | | o Distal Clavicle plates | Yes | Yes | Yes | Yes | Yes | | o Fixation system | Combination of locking and non- locking screws | Combination of locking and non- locking screws | Combination of locking and non- locking screws | Combination of locking and non- locking screws | Combination of locking and non- locking screws | | Materials | | | | | | | o Plates | Titanium | Titanium | Titanium | Titanium or stainless steel | Stainless steel | | o Screws | Titanium | Titanium | Titanium | Titanium or stainless steel | Stainless steel | | o Anodization | Yes | No | Yes | Yes | No | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Newclip Technics. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above the word "NEWCLIP" is a curved line that resembles a clip. # 6. Intended use: The implants of the Newclip Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. # 7. Non-clinical Test Summary: The following tests were conducted: - Comparative bending test on Clavicle plates according ASTM F 382-99 . Annex Al. - Comparative fatigue test on Lateral Clavicle plates according ASTM F 382 -. 99 - Annex A2. - Comparative torsional test on each type of screws according ASTM F543-07 . Annex A1. - Comparative mechanical pullout test on each type of screws according to . ASTM F543-07 Annex A3. ## 8. Non-clinical Test Summary: No clinical studies were performed. # 9. Conclusions Nonclinical and Clinical: The Newclip Clavicle Locking Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Newclip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681 0(T 2 2 2010 Re: K100944 Trade/Device Name: Clavicle Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: HRS, HWC Dated: September 29, 2010 Received: October 4, 2010 Dear Mr. Webb: 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, 7 rug and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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 {5}------------------------------------------------ Page 2 - Mr. J.D. Webb 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Barbara Buend Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosúre {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" in smaller, lighter letters. Above the word "NEWCLIP" is a curved line that resembles a sunrise. K100944 OCT 22 2010 # INDICATIONS FOR USE 510(k) Number (if known): K1009944 Device Name: Clavicle Locking Plating System Indications for Use: The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. > Prescription Use AND/OR Part 21 CFR 801 Subpart D) 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) -Page 1 of Seneta for mxn (Division Sign Off Division of Surgical, Inthopedic, and Restorative Devices 510(k) Number K100944