(14 days)
Not Found
No
The summary describes standard bone screws and their mechanical properties, with no mention of AI or ML.
No.
The device description and intended use indicate that the ORTHOLOC™ Bone Screws are fixation devices used in bone reconstruction, fracture repair, and fusion, which are surgical and supportive functions, not therapeutic. Therapeutic devices generally aim to treat or cure a disease or condition, which these screws do not directly do; they provide structural support for healing.
No
The device, ORTHOLOC™ Bone Screws, is used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are treatment procedures and do not involve diagnosing a condition.
No
The device description explicitly states the device is a bone screw manufactured from titanium alloy, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ORTHOLOC™ Bone Screws are for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are all surgical procedures performed in vivo (within the living body).
- Device Description: The device is described as bone screws made from titanium alloy, which are implants used directly in the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The ORTHOLOC™ Bone Screws are implants used in vivo for structural support and fixation within the bone, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ORTHOLOC™ Bone Screws subject to this premarket notification include the nonlocking 3.5mm low profile cortical bone screws and non-locking 3.5 and 4.0 cortical bone screws. These screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
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)
Substantial equivalence is shown through worst-case pull out testing, materials information, and comparison of design characteristics. The results show that the subject ORTHQLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOCTM Bone Screws and Wright Compression 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.
K102429-ORTHOLOC™ 3Di Ankle System and ORTHOLOC™ Bone Screws, K082320-WrightTM Compression Screws
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
Image /page/0/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic consisting of three angled shapes. At the top of the image, there is a handwritten number "K112772(1/2)".
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
OCT - 7 2011
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the URTHOLOC™ Bone Screws.
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------|
| Date: | August 29, 2011 |
| Contact Person: | Kellen Hills
Regulatory Affairs Specialist
(901) 290-5816 |
| A.2. Proprietary Name: | ORTHOLOC™ Bone Screws |
| Common Name: | Bone Screw |
| Device Classification Regulation: | 21 CFR 888.3040-Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation Bone
87 Orthopedics |
| A.3. Predicate Device: | K102429-ORTHOLOC™ 3Di Ankle
System and ORTHOLOC™ Bone Screws |
K082320-WrightTM Compression Screws
A.4. Device Description
The ORTHOLOC™ Bone Screws subject to this premarket notification include the nonlocking 3.5mm low profile cortical bone screws and non-locking 3.5 and 4.0 cortical bone screws.
These screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
A.5. Intended Use
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone
. ・ ...
Plating
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Image /page/1/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic design of three horizontal lines that are stacked on top of each other. Above the word "WRIGHT." is the text "K 112772 (2/2)".
A.6. Technological Characteristics Comparison
The subject ORTHOLOC™ Bone Screws are identical to the predicate ORTHOLOC™ Bone Screws with the exception of the radii at the transition from the screw head to the screw shaft. This change resulted in approximately one thread being removed from the distal portion of the screw.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence is shown through worst-case pull out testing, materials information, and comparison of design characteristics. The results show that the subject ORTHQLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOCTM Bone Screws and Wright Compression Screws.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through worst-case pull out testing, materials information, and comparison of design characteristics. The subject screws are identical in indication for use, diameter, size range and material to the predicates, and differ only in screw neck radii. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the serpent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc % Kellen Hill Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
OCT - 7 2011
Re: K112772
Trade/Device Name: ORTHOLOC"™ Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class H Product Code: HWC Dated: September 12, 2011 Received: September 23, 2011
Dear Kellen Hill:
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 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 lisuing (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
3
Page 2 – Kellen Hill
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (SF OF to Act); 21 CFR 1000-1050.
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 Parl 801), please If you desire specific advice for your cevree on var acconsideratives/ucm l 1589.html for go to http://www.fda.gov/Aboutr1787Ccmcrs0fffcs) Office of Connyliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) workst natification" (21CFF) P the Center for Devices and Radionogical Health Steans to premarket notification" (21CFR Part note the regulation entitled, "Misolanding of reference to promised in MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to Illip://www.ida.2017/01/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11
You may obtain other general information on your responsibilities under the Act from the You may obtain oner general mornation on your responsion.
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 (800) 038-2041 of (2017) 720 Devices/Resourcesfor You/Industry/default.h1m.
Sincerely yours,
Per
E. Melkerson
Mark N. Melkers Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K || 2772 (11)
Indications for Use
510(k) Number (if known):
Device Name: ORTHOLOC™ Bone Screws
Indications For Use:
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
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)
Mutheal Threis for mxm
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112772
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