(50 days)
Not Found
Not Found
No
The device description and performance studies indicate a purely mechanical function (providing a bearing surface) and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No.
The device is an accessory (washer) for a bone anchor system, intended to provide a bearing surface for a screw head, not to directly treat or diagnose a disease or condition.
No
The device description and intended use state that the BONE-LOK™ HP Washer is an accessory for a surgical system used in fracture management and reconstructive surgery. Its function is mechanical (providing a bearing surface and preventing screw migration) and does not involve diagnosing medical conditions.
No
The device description clearly states the device is a physical component (washer) made of Titanium and is intended for use with a surgical anchor system. It is provided non-sterile and requires sterilization. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general management of fractures and reconstructive surgery," which are surgical procedures performed directly on the patient's body.
- Device Description: The device is a physical washer made of titanium, designed to be implanted or used during surgery to support a screw in bone.
- Lack of Diagnostic Function: The device's function is purely mechanical and structural, providing a bearing surface and preventing screw migration. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HTN
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.
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)
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.
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.
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.
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
§ 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
K040250
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | Triage Medical, Inc |
|---|---|---|
| B. | Company Address: | 13700 Alton Parkway |
| Suite 160 | ||
| Irvine, CA 92618 | ||
| C. | Company Phone: | (949) 472-0006 |
| D. | Company Facsimile: | (949) 472-0016 |
| E. | Contact Person: | Gayle Hirota |
| Manager, Quality Assurance & Regulatory | ||
| Affairs | ||
| 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 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.
CONFIDENTIAL
1
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.
2
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.
3
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
4
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)
OR
Over-The-Counter Use
Mark N Mulkerson
for Division Sign-Off
Division of General Restorative. and Neurological Levices
ﻪ ﺩﺭ
CONFIDENTIAL
Number K040250