(27 days)
Not Found
No
The device description and intended use clearly define the device as a physical marker (bone screw) used for radiographic reference, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device serves as a marker for imaging and measurement, rather than actively treating a disease or condition.
No
The device is a radiopaque marker used during orthopedic or other surgical procedures to measure movement of implants or serve as a reference point. It does not diagnose diseases or conditions.
No
The device description clearly states it is a physical zirconium bone screw, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Self-Drilling Radiographic Markers are implanted into bone and used as physical markers for imaging (X-ray). They do not analyze biological specimens.
- Intended Use: The intended use is to measure movement of implants or locate anatomical structures using X-ray imaging, not to diagnose a condition based on biological samples.
Therefore, this device falls under the category of a surgical implant or accessory used in conjunction with medical imaging, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Self-Drilling Radiographic Markers arc zirconium 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
NEU
Device Description
The Self-drilling Radiographic Markers are zirconium 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 Xray. 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 13 2004
K04099D
TAB 2 - Summary of Safety and Effectiveness
510(k) Summary (per 21 CFR 807.92(c))
SUBMITTER
Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347
PRODUCT NAME
Common/Usual Name: Radiographic Marker
Proprietary Name: Sclf-Drilling Radiographic Marker
DEVICE CLASSIFICATION
The FDA has cleared radiographic markers via 510(k) Premarket Notification as Product Code THE FDA nas cicared radiographic 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.
PREDICATE DEVICE
The predicate device is the Stainless Stecl Self Drilling Radiographic Marker cleared under W. Lorenz 510(k) number K014148 on January 17, 2002.
DESCRIPTION OF DEVICE
The Self-drilling Radiographic Markers are zirconium 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 Xray. Self-drilling Radiographic Markers are applied with manual surgical instruments.
INTENDED USE OF THE DEVICE
The Self-Drilling Radiographic Markers arc zirconium 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.
STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES
Both the new and the old devices consist of non absorbable material (stainless steel, zirconium) Doth the FDA's Biomaterials Compendium and list of FDA recognized standards. Both the nsted in 1 Dre Dromaternal Sed devices are implanted into bone during surgical procedures precieee and and a surgical location (e.g. implant, prosthesis, or anatomic position). The metallic materials and intended use as radiographic markers are technically equivalent.
CONCLUSIONS
The use of modified zirconium screws and the predicate stainless steel screws as radiographic markers is substantially similar.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Ms. Kim Reed Senior Regulatory Specialist W. Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K040990
Trade/Device Name: Self-Drilling Radiographic Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Marker, radiographic, implantable Regulatory Class: II Product Code: NEU Dated: April 14, 2004 Received: April 16, 2004
Dear Ms. Reed:
We have reviewed your Scction 510(k) premarket notification of intent to market the device w & new le reveal 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 for assession in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or with to may 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetor For (. 10. (. 10.) the device, subject to the general controls provisions of the Act. The r ou may, itere, whiless of the Act include requirements for annual registration, listing of general beliable profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your de rise to such additional controls. Existing major regulations affecting your device can may or subject to basil and 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 equivalcnce determination does not mean r toabe oe actermination that your device complies with other requirements of the Act that 1197 Has Intatutes and regulations administered by other Federal agencies. You must or any I each 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 El It rate 6077, aboning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Kim Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mailering of substantial equivalence of your device to a legally premarket notification. THP PDF intembers on 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 if you desire specific acrepliance 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 other general mionmation 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,
Miriam C. Provost
(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
3
KO40920
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Self-Drilling Radiographic Markers Device Name: _________________________________________________________________________________________________________________________________________________________________
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 implantou into bone daving of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_________________________________________________________________________________________________________________________________________________________________