(30 days)
Not Found
No
The description focuses on the physical device (stainless steel bone screws) and its function as a radiopaque marker for manual measurement with X-rays. There is no mention of any software, algorithms, or data processing that would suggest AI/ML is involved.
No.
The device is used as a radiopaque marker to measure movement or serve as a reference point for anatomical structures, not to treat or diagnose a disease or condition.
No
The device is described as a radiopaque marker used to measure movement of implants or serve as a reference point. It facilitates diagnosis (by providing reference points for X-rays) but does not itself perform a diagnostic function or provide a medical diagnosis of a condition or disease.
No
The device description clearly states it is a physical object (stainless steel bone screws) used as radiographic markers, which are implanted into bone. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Self-Drilling Radiographic Markers described are physical implants used in vivo (within the body) during surgical procedures. Their purpose is to serve as physical reference points for imaging (X-ray) to measure movement or locate structures. They do not analyze biological samples.
The description clearly indicates the device is a surgical implant used in the patient's bone, not a test performed on a sample from the patient.
N/A
Intended Use / Indications for Use
The Self-Drilling Radiographic Markers are stainless steel screws indicated for use as radiographic markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.
Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
Self-Drilling Radiographic Markers are stainless steel bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an X-ray. Self-Drilling Radiographic Markers are applied with manual surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic or other surgical procedures
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)
Not Found
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.
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K014148 (P.1 of 2)
510(k) SUMMARY (per 21 CFR 807.92 (c))
1. SUBMITTER
JAN 1 7 2002
Walter Lorenz Surgical, Inc.* 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347
*Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580 FDA Registration Number: 1825034
2. PRODUCT NAME
Common/Usual Name: Radiographic Marker
Proprietary Name: Self-Drilling Radiographic Marker
3. DEVICE CLASSIFICATION
The FDA has cleared radiographic markers via 510(k) Premarket Notifications as Product Code NEU Marker, Radiographic, Implantable -Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for implantable radiographic markers.
4. PREDICATE DEVICE
The predicate device is the Tantalum Bead - Radiographic Marker cleared under Biomet 510(k) number K010348 on May 3, 2001.
5. DESCRIPTION OF THE DEVICE
Self-Drilling Radiographic Markers are stainless steel bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an X-ray. Self-Drilling Radiographic Markers are applied with manual surgical instruments.
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1
K014148 (P.2 of 2)
6. INTENDED USE OF THE DEVICE
The Self-Drilling Radiographic Markers are stainless steel screws indicated for use as radiographic markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.
7. STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES
Both the new and predicate devices consist of non absorbable material (stainless steel, tantalum) listed in the FDA's Biomaterials Compendium and list of FDA recognized standards. Both the predicate devices and the modified self-drilling devices are implanted into bone during surgical procedures to radiographically mark a surgical location (e.g. implant, prosthesis, or anatomic position). The metallic materials and intended use as radiographic markers are technically equivalent. The modified device is being added to resolve differences in surgeon preference.
8. CONCLUSIONS
The use of modified stainless steel screws and the predicate tantalum beads as radiographic markers is substantially similar.
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K014148
Trade/Device Name: Self-Drilling Radiographic Markers Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 17, 2001 Received: December 18, 2001
Dear Ms. Reed:
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. Kim Reed
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark A. Melham
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number K014148
Device Name: Self-Drilling Radiographic Markers
Indications for Use:
Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.
(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 | |
| (Optional Format 1-2-96) |
for
(Division Sign-Off)
Division of General, ative
and Neurological De.....
| 510(k) Number | K014148 |
|---|---|
| --------------- | --------- |
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