K Number
K063460
Device Name
ACUMED CONGRUENT BONE PLATE SYSTEM
Manufacturer
Date Cleared
2006-12-07

(22 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.
Device Description
The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.
More Information

Not Found

No
The 510(k) summary describes a traditional bone plate and screw system made of standard materials, with no mention of AI, ML, image processing, or any software-driven features that would suggest the use of such technologies.

Yes
The device is described as providing "fixation for fractures, fusions, or osteotomies," which are all therapeutic interventions aimed at treating medical conditions.

No
The device is described as a bone plate system used for fixation of fractures, fusions, or osteotomies, which are treatment procedures rather than diagnostic ones.

No

The device description explicitly states it consists of bone plates and screws made from titanium and stainless steel, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "fixation for fractures, fusions, or osteotomies" of various bones. This is a surgical procedure performed directly on the patient's body.
  • Device Description: The description details bone plates and screws made of titanium and stainless steel, along with instruments for insertion. This aligns with surgical implants and tools.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.

Therefore, the Acumed Congruent Bone Plate System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

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

HRS

Device Description

The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

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)

An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.

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.

K012655

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

§ 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.

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits. The digits appear to be '1063460'. The handwriting is somewhat stylized, with some digits slightly overlapping or connected. The image has a simple, monochrome appearance.

ACUMEDILLO

5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432

Tel (503) 627-9957

510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Submitter Information: Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, OR 97124-9432 USA Phone: (503) 627-9957 FAX: (503) 686-7102 Contact: Ed Boehmer, Regulatory Compliance Officer

Classification Name:Single/multiple Component Metallic Bone Fixation Appliances and
Accessories
Common Name:Plate, Fixation, Bone
Proprietary Name:Acumed Congruent Bone Plate System
Proposed Regulatory Class:Class II, 21 CFR 888.3030
Device Product Code:HRS
Legally Marketed Equivalent Device(s):Acumed LLC Congruent Bone Plate System K012655

Device Description: The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

Intended Use: The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The Acumed Scapula Congruent Bone Plate System is made out of Titanium as per ASTM F136 and Stainless Steel ASTM F138 and ASTM F2229. The predicates devices listed use similar materials

An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.

Based upon the similarities of the Acumed Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Congruent Bone Plate System is substantially equivalent to the predicate devices referenced.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 7 2006

Acumed, LLC % Mr. Ed Boehmer Regulatory Compliance Officer 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124

Re: K063460 Trade/Device Name: Acumed Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 10, 2006 Received: November 15, 2006

Dear Mr. Boehmer:

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. Ed Boehmer

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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Obalbag Buell

Mark N. Melkerson 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

510(k) Number (if known):

Acumed Congruent Bone Plate System Device Name:

Indications For Use:

The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Barbara Brehind for mcm

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

510(k) Number K063460

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