Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical coupling for an external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is described as an external fixation system component used in the stabilization of fractures, which is a treatment for a medical condition.

Diagnostic

No
The device is described as a coupling for an external fixation system used for stabilizing fractures, which is a treatment and not a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is fabricated from stainless steel and aluminum, indicating it is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

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 use, not a diagnostic one.
Device Description: The description details a mechanical component used in an external fixation system. It does not mention any reagents, samples, or analysis of biological specimens, which are characteristic of IVDs.
Lack of IVD Keywords: There are no mentions of terms typically associated with IVDs such as "in vitro," "diagnostic," "assay," "sample," "reagent," "analyte," etc.

IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to stabilize bones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hoffmann® II Compact™ Baltimore Coupling is intended to be used with the components of the Hoffmann® II Compact™ External Fixation System and in conjunction with 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 such as IM rodding, casting, or other means of internal fixation.

Product codes (comma separated list FDA assigned to the subject device)

JEC

Device Description

This Special 510(k) submission is intended to address the introduction of a supplemental component to the predicate Hoffmann® II Compact External Fixation System. The subject device, named the Hoffmann® II Compact™ Baltimore Coupling, is a line extension of the Hoffmann® II Compact "Rod to Rod Coupling. The predicate Hoffmann® II Compact™ Rod Coupling is fabricated from stainless steel and aluminum. The subject Hoffmann® II Compact™ Baltimore Clamp is also fabricated from stainless steel and aluminum. The Hoffmann® II Compact™ Baltimore Coupling is a modification of the Hoffmann® II Compact" Rod to Rod Coupling. The modification involves a change to the rod to clamp interface which includes a change in profile, an added lip to provide resistance to rod slippage and chamfered edges to aid in rod insertion. Both the predicate Hoffmann® II Compact™ Rod to Rod Coupling and the subject Hoffmann® II Compact™ Baltimore Coupling will be made available to provide surgeons with a choice of couplings for use with the Hoffman® II Compact™ External Fixation 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)

Mechanical testing demonstrated comparable mechanical properties to the predicate component.

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

Summary

0

Line Extension to the Hoffmann® II Compact External Fixation System Hoffmann® II Compact™ Baltimore Coupling

pecial 510(k) Premarket Notification

JUL 2 4 2003

K031941
page 1 of 1

Summary of Safety and Effectiveness Line Extension to the Hoffmann® II Compact™ External Fixation System -Hoffmann® II Compact™ Baltimore Coupling

Submission Information

| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Kelly
Regulatory Affairs Consultant
Phone: 201-831-5581
Fax: 201-831-6038 |
| Date of Summary Preparation: | June 20, 2003 |
| Device Identification | |
| Proprietary Name: | Hoffmann® II Compact™ Baltimore Coupling |
| Common Name: | External Fixation Frame Component |

Classification Name and Reference: Smooth or threaded metallic bone fixation fastener, 21 CFR §888.3040

This Special 510(k) submission is intended to address the introduction of a supplemental component to the predicate Hoffmann® II Compact External Fixation System. The subject device, named the Hoffmann® II Compact™ Baltimore Coupling, is a line extension of the Hoffmann® II Compact "Rod to Rod Coupling. The predicate Hoffmann® II Compact™ Rod Coupling is fabricated from stainless steel and aluminum. The subject Hoffmann® II Compact™ Baltimore Clamp is also fabricated from stainless steel and aluminum. The Hoffmann® II Compact™ Baltimore Coupling is a modification of the Hoffmann® II Compact" Rod to Rod Coupling. The modification involves a change to the rod to clamp interface which includes a change in profile, an added lip to provide resistance to rod slippage and chamfered edges to aid in rod insertion. Both the predicate Hoffmann® II Compact™ Rod to Rod Coupling and the subject Hoffmann® II Compact™ Baltimore Coupling will be made available to provide surgeons with a choice of couplings for use with the Hoffman® II Compact™ External Fixation System.

The subject Hoffmann® II Compact™ Baltimore Coupling has the same intended use and basic design concepts as the currently available Hoffmann® II Compact™ External Fixation System Rod to Rod Coupling. Mechanical testing demonstrated comparable mechanical properties to the predicate component.

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing to the left and has its head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031941

Trade/Device Name: Hoffmann® II Compact™ Baltimore Coupling Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: June 20, 2003 Received: June 24, 2003

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 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 - 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" (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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

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

3

510(k) Number (if known): K 031941

Device Name: Hoffmann® II Compact™ Baltimore Coupling

Indications For Use:

The Hoffmann® II Compact™ Baltimore Coupling is intended to be used with the components of the Hoffmann® II Compact™ External Fixation System and in conjunction with 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 such as IM rodding, casting, or 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 Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for Mark n Mckinion
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K031941