Who is the manufacturer of DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

Hand Innovations, Inc. filed the 510(k) submission for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (K050932).

What is the FDA product code for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

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

What is the regulatory pathway for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

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

What are the predicate devices for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

Distal Volar Radius Plate System (K032705).

Who can help prepare an FDA 510(k) submission like DISTAL VOLAR RADIUS ANATOMICAL 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.

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM

K050932 · Hand Innovations, Inc. · LXT · Apr 26, 2005 · Orthopedic

Device Facts

Record ID	K050932
Device Name	DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
Applicant	Hand Innovations, Inc.
Product Code	LXT · Orthopedic
Decision Date	Apr 26, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

Device Story

Distal Volar Radius Anatomical Plate System is an orthopedic implant set for distal radius fracture and osteotomy fixation. System includes titanium plates (Distal Volar Plates, Distal Dorsal Nail Plate), pegs, and screws. Provided in a sterilization tray with reusable instruments (peg drivers) and non-reusable instruments (F.A.S.T. Guide Technology drill guide, drill bits). Used by surgeons in clinical/OR settings to stabilize bone segments during healing. Device functions as a mechanical fixation system; no electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence supported by pre-clinical testing.

Technological Characteristics

Metallic bone fixation system. Materials: Titanium meeting ASTM F 136-96. Components: Plates, pegs, screws. Includes drill guides and bits. Sterilization tray provided.

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal radius.

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

Distal Volar Radius Plate System (K032705)

Related Devices

K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 · Kapp Surgical Instrument, Inc. · Aug 8, 2005
K030198 — HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM · Hand Innovations, Inc. · Apr 1, 2003
K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW · Biomet · Oct 9, 2013
K033756 — VOLAR RADIUS PLATE WITH ANGULAR STABILITY · I.T.S. Implantat-Technologie-Systeme GmbH · Feb 6, 2004
K191641 — AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws · Industrias Medicas Sampedro S.A.S · Sep 16, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ APR 2 6 2005 K050932 000043 ## 510(k) Summary of Safety and Effectiveness | General Provisions | The name of the device is: | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | | Proprietary Name | Common or Usual Name | | | Distal Volar Radius Anatomical Plate System | Plate Fixation Bone | | Name of Predicate Devices | The device is substantially equivalent to: • Distal Volar Radius Plate System (510(k) # K032705 – October 1, 2003) – Hand Innovations, Inc. | | | Classification | Class II. | | | Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. | | | Indications for Use | The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius. | | | Device Description | The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits | | | Biocompati- bility | The implantable components of the Distal Volar Radius Anatomical Plate System and instruments do not require biocompatibility testing because the titanium used in fabrications meets the requirements of ASTM F 136-96. | | | Summary of Substantial Equivalence | The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System. The equivalence was confirmed through pre-clinical testing. | | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing a stylized human figure or a symbol of health and well-being. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 6 2005 Mr. Ernesto Hernandez COO, Vice President RA/QA Hand Innovations, Inc. 8905 SW Avenue, Suite 220 Miami, Florida 33176 Re: K050932 Trade/Device Name: Distal Volar Radius Anatomical Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: April 13, 2005 Received: April 14, 2005 Dear Mr. Hernandez: 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 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. {2}------------------------------------------------ Page 2 - Mr. Ernesto Hernandez 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, Ruleta Miriam C. Provost, Ph.D. (一 Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): _______________________ Page of of ___ Device Name: Distal Volar Radius Anatomical Plate System ## Indications for Use Statement The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .. . ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Erich-Thomsen 021012 018. POT ivision of General, Restorative and Neurologics! Devices Distal Volar Radius Anatomical Plate System Special 510(k) April 13, 2005 KOS0932