(78 days)
Not Found
No
The summary describes a mechanical external fixation system and mentions no software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is used for "stabilization of open and/or unstable fractures," which is a therapeutic treatment.
No
Explanation: This device is an external fixation system used for stabilizing fractures, not for diagnosing medical conditions. Its intended use describes treatment, not diagnosis.
No
The device description explicitly states it is fabricated from stainless steel components and carbon connecting rods, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "stabilization of open and/or unstable fractures." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description mentions "stainless steel components and carbon connecting rods," which are typical materials for surgical implants and external fixation devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
Product codes
KTT, LXT, JEC
Device Description
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Micro "External Fixation System. The subject and predicate Hoffmann® II Micro" External Fixation Systems are both fabricated from stainless steel components and carbon connecting rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical testing demonstrated comparable mechanical properties to the predicate components.
Key Metrics
Not Found
Predicate Device(s)
Hoffmann® II Micro™ External Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Summary of Safety and Effectiveness Hoffmann® II Micro™ External Fixation System Line Extension
Proprietary Name: System
Common Name:
Classification Name and Reference
Device Product Code:
For Information contact:
Hoffmann® II Micro™ External Fixation
External Fixation Frame Component
Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030
87 KTT, 87 LXT & 87 JEC
Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared:
December 5, 2003
Description:
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Micro "External Fixation System. The subject and predicate Hoffmann® II Micro" External Fixation Systems are both fabricated from stainless steel components and carbon connecting rods.
Intended Use:
The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other mcans of internal fixation.
Substantial Equivalence:
The subject Hoffmann® II Micro " External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Micro™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract caduceus symbol, which is a symbol associated with healthcare and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Stryker Howmedica Osteonics, Corp. 59 Route 17 South Allendale, NJ 07401
Re: K033476
Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastener, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codc: KTT, LXT, JEC Dated: January 6, 2004 Received: January 7, 2004
Dear Ms. Kelly:
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 Amendnients, 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 adultcration.
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Ms. Vivian Kelly
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 (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 8,07.97). 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/dsma/dsmamain.html
Sincerely yours,
l Mark n Wilkerson
elia M. Witten, Ph.D., M.D., M.D 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): K033476
Device Name: Hoffmann® II Micro External Fixation System
Indications For Use:
The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
for Mark A. Millman