(253 days)
Not Found
No
The summary describes a mechanical bone screw and its intended use, with no mention of AI/ML technology, image processing, or data-driven performance metrics.
Yes.
The device is used for fracture repair and fixation, which are direct treatments for a medical condition.
No
The device, a locking bone screw, is indicated for surgical procedures like bone reconstruction and fracture fixation. It is a therapy device, not a diagnostic one.
No
The device description explicitly states the device is made of Titanium Alloy and is a physical bone screw, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures involving bone (reconstruction, osteotomy, fracture repair, etc.). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a physical implant made of titanium alloy, designed to be used with a bone plate. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone screw does not fit that description.
N/A
Intended Use / Indications for Use
Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bonc reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests were performed per the following standards: ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws.
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.
Merete 3.5mm Locking Screws as cleared under K081513.
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
§ 888.3040 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.
0
Exhibit #2 510(k) Summary for K100721
NOV 2 3 2010
Exhibit #2 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) Number: _K100721
- Date of Prepared: 12Nov 2010 1.
Proposed Device Identification 2.
Trade/ Proprietary Name:Locking Bone Screw
Common Name:Smooth or threaded metallic bone fixation fastener
Classification Name:Screw, fixation, bone
Device Class: Il
Product Code:HWC
Regulation Number: 21 CFR 888.3040
Intended Use:
I wone Screw isindicated for bone reconstruction, osteotomy, arthrodesis, joint fusion,fracture repair, and fracture fixation of bones appropriate for the size of the device.
Sponsor Information 3.
Establishment Registration Number: 3005597716 Changzhou Orthmed Medical Instrument Co.,Ltd No.177, Qinling Road, New Zone, Changzhou, Jiangsu, China, 213022 Phone: +86-519-85123770-8055 .Fax:+86-519-85123776
Submission Correspondent
Ms. Diana Hong, Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 20030, China Tcl: +86-21-64264467 Fax: 240-238-7587 Email: Diana.hong@mid-link.net
loR2
1
Predicate Device Identification 4.
Merete 3.5mm Locking Screws as cleared under K081513.
ડ. Device Description
The proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meetsASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bonc reconstruction,osteotomy, arthrodesis, joint fusion,fracture repair, and fracture fixation of bones appropriate for the size of the device.
| Model Name | HCQ04
(Normal Head) | HC5Q04
(Normal Head/
Flat Head) | HCQ04
(Normal Head) | HCZ04
(Tapered Head) |
|---------------|------------------------|---------------------------------------|------------------------|-------------------------|
| Diameter (mm) | 3.5 | 5.0 | 6.5 | 5.0 |
| Length(mm) | 1065120
every 1mm | 10
every 1mm | 2012085
every 1mm | 18
every 1mm |
Table 1 Specifications
Substantially Equivalence 6.
Both the proposed and predicate device has same classification, similar intended use. Both of them were made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1. The performance test was performed on both, the result demonstrated that they have similar performance. Therefore, the proposed device, Locking Bone Screw, is determined to be Substantially Equivalent (SE) to the predicate device, Merete 3.5mm Locking Screws as cleared under K081513.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests were performed per the following standards: ASTM F543-07, Standard Specification and Test Methods for Metallic Medical BoneScrews.
100
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Changzhou Orthmed Medical Instrument Co., Ltd. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diane Hong Suite 5D, No. 19, Lane 999 Zhongshan No.2 Road (S) Shanghai, China 20030
NOV 2 3 2013
Re: K100721
Trade/Device Name: Locking Bone Screw Model HCO04. HCZ04 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 12, 2010 Received: November 15, 2010
Dear Ms. Hong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device cran he 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
3
Page 2 - Ms. Diane Hong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbara Buchmu
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K10072 510(k) Number:
NOV 2 3 2010
- CALL - CALL - CALL - COMMER - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CA
Device Name: Locking Bone Screw
Indications for Use:
Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smata for nym
(Division Signa)
ision Sig vision of Surgica! Orthopedic, and Restorative Devices
510(k) Number K100721