Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components (plates, screws, instruments) for fracture fixation and makes no mention of AI or ML.

Therapeutic

Yes
The device is used for "fixation of fractures and osteotomies," which are medical conditions, and thus it directly treats or alleviates a disease or injury.

Diagnostic

No
The device is used for fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of physical components like titanium plates, screws, and surgical instruments, which are hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "fixation of fractures and osteotomies involving the distal radius." This is a surgical procedure performed directly on the patient's body.
Device Description: The description details plates, screws, and surgical instruments used for internal fixation. These are all physical implants and tools used in surgery.
Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.

The Mondeal® RADIUS HO System is a surgical implant and instrument system used for orthopedic procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Mondeal® Radius Hand Osteosynthesis System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

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

HRS

Device Description

The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

distal radius

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Not Found

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.

Synthes (USA) Distal Radius Plate System (DRPS) and Hand Innovations, Inc. Distal Radius Fracture Repair System

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

§ 888.3030 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.

Summary

0

Kapp Surgical Instrument, Inc.

510(k) Notification: Mondeal® Radius HO

Attachment 1 – 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance This Summary of 510(R) Surety and 21 CFR 807.92, upon which the substantial equivalence determination is based.

Summary Information:

| Applicant: | Kapp Surgical Instrument Co., Inc.
4919 Warrensville Center Road
Warrensville Heights, Ohio 44128
Tel: (216) 587-4400
Fax: (216) 587-0411 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact : | Albert Santilli, President |
| Prepared: | March 10, 2005 |
| Device Identification: | |
| Proprietary Name: | Mondeal® RADIUS HO System |
| Common Name: | Screw, Fixation, Bone and Plate, Fixation, Bone |
| Classification Name
and Regulation: | Plate, Fixation, Bone, Class II
21 CFR 888.3030, 87HRS |
| Predicate Device(s): | Synthes (USA) Distal Radius Plate System (DRPS) and
Hand Innovations, Inc. Distal Radius Fracture Repair System |

Device Description:

The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation

Indications for use:

The Mondeal® Radius Hand Osteosynthesis System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Substantial Equivalence:

KAPP Surgical Instrument Co., Inc. considers the Mondeal® RADIUS HO System to be substantially equivalent to the aforementioned predicate devices with regard to intended use, materials, biocompatibility, and overall performance characteristics in accordance with the following comparison summary.

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Attribute	Candidate Device	Predicate Devices
Product Name	Mondeal® RADIUS
HO System	Hand Innovation Distal
Radius Fracture Repair	SYNTHES (USA)
Radius Plate System
Use	Single Use, Permanent	Single Use, Permanent	Single Use, Permanent
Plate and Screw Material	Ti-6Al-4V ELI plates
and screws	Ti-6Al-4V ELI plates
pegs, and screws	Titanium alloy and
titanium plates and
screws
Sizes	2.7 mm x 8 - 32 mm
3.0 mm x 8 - 32 mm	2.5mm x 10 - 28 mm	1.8mm x 10 - 26 mm
2.4mm x 10 - 26 mm
Available configurations	Right and left volar and
dorsal	Right and left volar and
dorsal	Right and left volar and
dorsal
Indications for use:	Intended for the fixation
of fractures and
osteotomies involving
the distal radius applied
to the volar and dorsal
aspects	Intended for the fixation
of fractures and
osteotomies involving
the distal radius	Intended for the fixation
of fractures and
osteotomies involving
the distal radius applied
to the volar and dorsal
aspects
Recommended
sterilisation method	Steam	Steam	Steam
Packaging	Tempered plastic and
stainless steel trays
intended for steam
sterilisation including
plate, screw, and hand
tool (Class I)
assortment, plates and
screws also packaged
individually, all non-
sterile, intended for
sterilisation by
purchaser.	Tempered plastic and
stainless steel trays
intended for steam
sterilisation including
plate, screw, and hand
tool (Class I)
assortment, plates and
screws also packaged
individually, all non-
sterile, intended for
sterilisation by
purchaser.	Stainless steel trays
intended for steam
sterilisation including
plate, screw, and hand
tool (Class I)
assortment, all non-
sterile, intended for
sterilisation by
purchaser.

Comparison to the Predicate Devices:

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2005

Albert Santilli, Ph.D. Kapp Surgical Instrument Co., Inc. 4919 Warrensville Center Road Warrensville Heights, Ohio 44128

Re: K050655

Trade/Device Name: Mondeal® RADIUS HO System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 1, 2005 Received: July 5, 2005

Dear Dr. Santilli:

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.

3

Page 2 - Albert Santilli, Ph.D.

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,

Mark H. Miken

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

KOSD655 |510(k)] Number:

Device Name: Mondeal® RADIUS HO System

Indications For Use:

The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

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

510(k) Number_