HBS HEADLESS BONE SCREW

K030302 · Schoening & Assoc., Inc. · HWC · Aug 8, 2003 · Orthopedic

Device Facts

• Record ID: K030302
• Device Name: HBS HEADLESS BONE SCREW
• Applicant: Schoening & Assoc., Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Headless bone screw system for the fixation of osseous fragments or fractures including: HBS - MINI Scaphoid fractures Lunate fractures Capitate Trapezial fractures Metacarpal and metatarsal fractures Phalangeal fractures Radial head fractures Ulnar styloid fractures Osteo-chrondral Small joint fusions Small joint fusions HBS - STANDARD Scaphoid fractures Carpal fractures & non-unions Capitellum fractures Metacarpal fractures Phalangeal fractures Distal radial fractures Radial head fractures Ulnar styloid fractures Small joint fusions Humeral head fractures Glenoid fractures Intercarpal fusions Interphalangeal fractures Metatarsal osteotomies Tarsal fusions Malleolar fractures Patellar fractures Osteo-chrondral fractures Odontoid fractures Mandibular fractures

Device Story

HBS Headless Bone Screw system provides internal fixation for bone fractures and osteotomies. Device consists of metallic screws designed for compression of osseous fragments. Used by orthopedic surgeons in clinical or surgical settings. Screws are implanted to stabilize bone segments, promoting healing and fusion. Benefit includes rigid fixation of small bone fragments and joints, facilitating patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; headless screw design; intended for internal bone fixation. Class II device under 21 CFR 888.3040.

Indications for Use

Indicated for fixation of osseous fragments or fractures in patients requiring bone stabilization, including scaphoid, carpal, metacarpal, metatarsal, phalangeal, radial head, ulnar styloid, humeral head, glenoid, malleolar, patellar, odontoid, and mandibular fractures, as well as small joint fusions and osteotomies.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border of the circle. In the center of the seal is a stylized image of an eagle with three curved lines extending from its head.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Schoening & Associates, Inc. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K030302

Trade/Device Name: HBS Headless Bone Screw Regulation Number: 21CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 23, 2003 Received: July 24, 2003

Dear Mr. Walls:

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

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## Page 2 - Mr. Kevin Walls, RAC

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K. 0.3030 d

HBS Headless Bone Screw Device Name:

Indications for Use:

Headless bone screw system for the fixation of osseous fragments or fractures including:

| HBS - MINI | HBS - STANDARD |
|-------------------------------------|-------------------------------|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures & non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chrondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Small joint fusions | Glenoid fractures |
| | Intercarpal fusions |
| | Interphalangeal fractures |
| | Metatarsal osteotomies |
| | Tarsal fusions |
| | Malleolar fractures |
| | Patellar fractures |
| | Osteo-chrondral fractures |
| | Odontoid fractures |
| | Mandibular fractures |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative And Neurological Devices 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030302