The BONE-LOK™ HP Washer is an accessory intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.

Device Description

The BONE-LOK™ HP Washer is intended for use with BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery. The washer provides a bearing surface for the screw head against the bone and also prohibits migration of the screw head into the cortex.
The BONE-LOK™ HP Washer is fabricated from Titanium 6AI-4V ELI, which meets the requirements of ASTM-136.
The BONE-LOK™ HP Washer is provided "NON-STERILE" and will require subsequent sterilization on site. The BONE-LOK™ HP Washer will be supplied as a part of the BONE-LOK™ HP Instrument Kit or as individual units packaged in a labeled poly bag. The Instrument Kit is distributed in a custom autoclavable compartmentalized tray with a locking lid. Both the BONE-LOK™ HP Washer and the Instrument Kit may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134). Sterilization instructions are included in the Instructions for Use.

AI/ML Overview

Here's an analysis of the provided text regarding the BONE-LOK™ HP Washer, focusing on acceptance criteria and supporting studies:

This medical device submission (K040250) is for a mechanical washer, not a software or AI-powered device. Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/software device (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria for a mechanical device like this often revolve around material properties, mechanical performance, and biocompatibility, typically demonstrated through in vitro testing or by leveraging existing knowledge about similar devices and materials.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from description)	Reported Device Performance (from text)
Material Composition	Fabricated from a biocompatible surgical-grade material suitable for implants.	Fabricated from Titanium 6Al-4V ELI, meeting ASTM-136 requirements.
Mechanical Functionality	Provides a bearing surface for a screw head against bone; Prohibits migration of the screw head into the cortex.	The BONE-LOK™ HP Washer "sole function... is to provide a bearing surface for the screw head against the bone and prohibit migration of the screw head into the cortex."
Design/Construction	Similar in basic design and construction to predicate devices.	"The BONE-LOK™ HP Washer is similar in basic materials, design, construction and mechanical performance to the predicate devices."
Intended Use	Suitable for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System in general management of fractures and reconstructive surgery.	"Intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery." (Matches description of predicate)
Biocompatibility	Biocompatible and inert in the human body.	"Made from Titanium 6Al-4V ELI, which meets the requirements of ASTM-136. This material is currently being utilized in a myriad of legally marketed devices. Because its inertness and biocompatibility has already been established, additional testing is not required."
Sterilization	Capable of effective sterilization by moist heat.	"Provided 'NON-STERILE' and will require subsequent sterilization on site... may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134)."

Study Details (as applicable to this type of device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the sense of a test set for a software/AI device. The "testing" here refers to the inherent properties of the material and the established history of use for this type of device and material. No specific "test set" of cases or data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" establishment in the context of image interpretation or diagnostic accuracy for this mechanical washer. The "truth" is based on material specifications and mechanical function.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is relevant for this type of device submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a mechanical washer, not an AI or software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical washer, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the traditional sense. The "ground truth" for this device's safety and effectiveness is derived from:
  - Material specifications: ASTM-136 for Titanium 6Al-4V ELI.
  - Accepted engineering principles: For its function as a washer.
  - Established clinical use: Of similar devices and the material itself for biocompatibility.
The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model.
How the ground truth for the training set was established
- Not applicable.

Summary of the "Study" for the BONE-LOK™ HP Washer:

The core of the submission's "performance data" and "biocompatibility" sections relies on demonstrating substantial equivalence to predicate devices and leveraging well-established material properties and clinical history.

The document explicitly states:

"Because the washer is fabricated from a material with specified mechanical requirements, is of limited functionality, and washers have been previously utilized in this capacity, additional testing is not required." (Performance Data)
"Because its inertness and biocompatibility has already been established, additional testing is not required." (Biocompatibility)

This means the "study" demonstrating the device meets acceptance criteria is primarily a literature review and comparison to legally marketed predicate devices and established material standards, rather than de novo experimental studies with test sets, expert ground truth, or statistical analysis typical for AI/software. The substantial equivalence argument is the primary "proof" used here.

Summary

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K040250

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER INFORMATION

A.	Company Name:	Triage Medical, Inc
B.	Company Address:	13700 Alton ParkwaySuite 160Irvine, CA 92618
C.	Company Phone:	(949) 472-0006
D.	Company Facsimile:	(949) 472-0016
E.	Contact Person:	Gayle HirotaManager, Quality Assurance & RegulatoryAffairs
DEVICE IDENTIFICATION

A.	Trade Name:	BONE-LOK™ HP Washer
B.	Catalog Number:	2057-00
C.	Common Name:	Washer
D.	Classification Name:	Washer, Bolt Nut
E.	Device Class:	Class II (per 21 CFR 888.3030)

IDENTIFICATION OF PREDICATE DEVICE

The Triage Washer is similar in design, materials, and intended use to the Synthes 13.0mm Washer and the Biomet Orthopedics Titanium Washer, 13mm.

DEVICE DESCRIPTION

The BONE-LOK™ HP Washer is fabricated from Titanium 6AI-4V ELI, which meets the requirements of ASTM-136.

CONFIDENTIAL

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K040250
page 2 of 2

The BONE-LOK™ HP Washer is provided "NON-STERILE" and will require subsequent sterilization on site. The BONE-LOK™ HP Washer will be supplied as a part of the BONE-LOK™ HP Instrument Kit or as individual units packaged in a labeled poly bag. The Instrument Kit is distributed in a custom autoclavable compartmentalized tray with a locking lid. Both the BONE-LOK™ HP Washer and the Instrument Kit may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134). Sterilization instructions are included in the Instructions for Use.

INTENDED USE

The BONE-LOK™ HP Washer is intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery.

TECHNOLOGICAL CHARACTERISTICS

The BONE-LOK™ HP Washer is similar in basic materials, design, construction and mechanical performance to the predicate devices.

PERFORMANCE DATA

The sole function of the BONE-LOK™ HP Washer is to provide a bearing surface for the screw head against the bone and prohibit migration of the screw head into the cortex. Because the washer is fabricated from a material with specified mechanical requirements, is of limited functionality, and washers have been previously utilized in this capacity, additional testing is not required.

BIOCOMPATIBILITY

The BONE-LOK™ HP Washer is made from Titanium 6Al-4V ELI, which meets the requirements of ASTM-136. This material is currently being utilized in a myriad of legally marketed devices. Because its inertness and biocompatibility has already been established, additional testing is not required.

CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the BONE-LOK™ HP Washer is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ms. Gavle Hirota Quality Assurance/Regulatory Affairs Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618

· Re: K040250

Trade/Device Name: BONE-LOK™ HP Washer Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: January 27, 2004 Received: February 2, 2004

Dear Ms. Hirota:

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.

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Page 2 - Ms. Gayle Hirota

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.

Muh A. Millerson

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

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INDICATIONS FOR USE

510(k) Number:

Ko4odsO

Device Name:

BONE-LOK™ HP Washer

Indications for Use:

The BONE-LOK™ HP Washer is an accessory intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Mark N Mulkerson
for Division Sign-Off

Division of General Restorative. and Neurological Levices

ﻪ ﺩﺭ

CONFIDENTIAL
Number K040250

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.