(77 days)
Not Found
Not Found
No
The device description and intended use focus on a mechanical clamp for external fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the "stabilization of open and/or unstable fractures," which is a therapeutic purpose.
No
The device is described as a clamp used for stabilization of fractures, and its function is to physically hold components together, not to diagnose a condition.
No
The device description clearly states it is a physical clamp made from plastic material, intended to be used with external fixation systems. It is a hardware component, not software.
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 and where soft tissue injury may preclude the use of other fracture treatments." This describes a surgical or orthopedic procedure, not a diagnostic test performed on biological samples.
- Device Description: The description details a "Periarticular Clamp" made of plastic, used with external fixation systems. This is a physical medical device used to stabilize bones, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
The device is a component of an external fixation system used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments.
Product codes
888.3040, KTT
Device Description
The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Original Hoffmann® Small 4-Hole Ball Joint, Hoffmann® II Compact External Fixation System, Agee-Wristjack (Hand Biomechanics Lab, Inc), Radiolucent Wrist Fixation System (Orthofix)
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
KA7 332)
510(k) Summary
Trade Name: Common Name: Classification Name: Hoffmann® II Compact Periarticular Clamp External Fixation Device Smooth or Threaded Metallic Bone Fixation Fastener 888.3040
The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System.
The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the Original Hoffmann® Small 4-Hole Ball Joint, Hoffmann® II Compact External Fixation System and an equivalence in material and intended use to the Agee-Wristjack (Hand Biomechanics Lab, Inc) and the Radiolucent Wrist Fixation System (Orthofix).
Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint.
The basic operational principles for the construction of external fixation frames is similar for this new clamp to those of the named external fixation devices, that is to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of clamps, couplings and rods. The method of site preparation, relative indications and contraindications for all the external fixation devices is similar.
| For information contact: | John Dichiara |
|---|---|
| Group Regulatory Affairs Manager | |
| Howmedica Inc. | |
| 359 Veterans Boulevard | |
| Rutherford, NJ 07070 | |
| (201) 507-7386 |
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Mr. John Dichiara Group Regulatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K973321 Hoffmann® II Compact Periarticular Clamp Requlatory Class: II Product Code: KTT September 3, 1997 Dated: Received: September 4, 1997
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John Dichiara
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
n Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not Known
Device Name: Hoffmann® II Compact Periarticular Clamp
Indications for Use:
The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments_ ___________________________________________________________________________________________________________________________________________________ . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
510(k) Numbe