(19 days)
Not Found
Not Found
No
The 510(k) summary describes simple orthopedic wires and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The intended use of the device is for procedures such as bone fracture fixation, osteotomy, arthrodesis, correction of deformity and bone reconstruction, all of which are therapeutic interventions.
No
Explanation: The device is described as orthopedic wires intended for surgical procedures like bone fracture fixation, osteotomy, and correction of deformity. This indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of it being used for detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly states the device is a physical orthopedic wire made of cobalt chromium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as being used in vivo (within the body) for orthopedic procedures like bone fracture fixation, osteotomy, etc.
- Device Description: The description details physical wires made of cobalt chromium alloy, designed for surgical implantation or manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and manipulation of bone.
N/A
Intended Use / Indications for Use
The subject orthopedic wires are single-use devices. Like the predicate devices, they are intended for:
- Bone fracture fixation, 등
- . Osteotomy,
- 바 Arthrodesis,
- Correction of deformity, 포
- Revision procedures where other treatments or devices have been unsuccessful, and; 미
- Bone reconstruction procedures. l
Product codes (comma separated list FDA assigned to the subject device)
87 JDQ
Device Description
The subject devices are also cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube (6 per tube), or as a 24" length, or as a 72" (6 Foot) coil. The subject devices are 0.0126", 0.0159", 0.020", 0.040" and 0.046" in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone
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)
No testing was performed to demonstrate the equivalence of the subject devices.
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
APR 2 8 2003
Line Extension to Orthopedic Wire
Image /page/0/Picture/2 description: The image shows the text "K031127 page 1 of 2" in a handwritten style. Below this text is the phrase "Special 510(k) Premarket Notification" in a smaller, more formal font. The text appears to be part of a document or report, possibly indicating a page number and a reference to a specific type of notification.
Special 510(k) Summary Line Extension to Orthopedic Wire
| Proprietary Name: | Orthopedic Wire |
|---|---|
| Common Name: | Orthopedic Wire |
| Classification Name and Reference: | Bone Fixation Cerclage |
| 21 CFR §888.3010 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 JDQ |
| Predicate Proprietary Name: | Orthopedic Wire |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | assumed to be 87 JDQ (preamendment device) |
| For Information contact: | Debra Bing |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| Phone: (201) 831-5413 | |
| Fax: (201) 831-6038 |
Description/Technological Comparison
The predicate devices are cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube, or as a 120" wire coil with an autoclavable clip. The predicate devices are 0.032" and 0.040" in diameter.
The subject devices are also cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube (6 per tube), or as a 24" length, or as a 72" (6 Foot) coil. The subject devices are 0.0126", 0.0159", 0.020", 0.040" and 0.046" in diameter.
1
Line Extension to Orthopedic Wire
03 1127
Page 2 of 2
Special 510(k) Premarket Notification
Intended Use
The subject orthopedic wires are single-use devices. Like the predicate devices, they are intended for:
- Bone fracture fixation, 등
- . Osteotomy,
- 바 Arthrodesis,
- Correction of deformity, 포
- Revision procedures where other treatments or devices have been unsuccessful, and; 미
- Bone reconstruction procedures. l
Testing Summary
No testing was performed to demonstrate the equivalence of the subject devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2003
Ms. Debra Bing Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K031127
Trade/Device Name: Line Extension - Orthopedic Wire Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDR Dated: April 4, 2003 Received: April 9, 2003
Dear Ms. Bing:
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
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,
Mark n Milkers
elia 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
510(k) Number (if known): KQ3/lv
Device Name: Line Extension - Orthopedic Wire
The subject orthopedic wires are single-use devices. They are intended for:
- Bone fracture fixation, 트
- 하 Osteotomy,
- 내 Arthrodesis,
- 해 Correction of deformity,
- . Revision procedures where other treatments or devices have been unsuccessful, and;
- 해 Bone reconstruction procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark A Milliken
Division Sign-Off) Division of General, Restorative and Neurological D 510(k) Number