(108 days)
Not Found
No
The device description and intended use clearly define the device as non-active bone surgery implants (screws) and associated tools, with no mention of AI or ML capabilities.
Yes
The device is a bone screw used for the treatment of bone fractures and fixation of transplanted bone blocks, indicating it is intended to treat a pathological condition.
No
The device is described as a non-active bone surgery implant used for the fixation of bone blocks and in combination with bone plates and meshes. Its function is to provide structural support, not to diagnose a condition.
No
The device description clearly states it is a bone screw, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that STOMA Bone Screws are "non-active bone surgery implants." They are physically implanted into the body to fix bone fractures and transplanted bone blocks.
- Intended Use: The intended use is for "bone surgery implants for the treatment of bone fractures... in the oral cavity and maxillomandibular surgical field." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity and maxillomandibular surgical field
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): 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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
STOMA Bone Screws
510(k) Notification
stoma Storz am Mark GmbH
K051871
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN AC-CORDANCE WITH SMDA OF 1990
DATE: 2005-08-22
APPLICANT: Storz am Mark GmbH Emminger Str. 39 D-78576 Emmingen-Liptingen Germany Phone: +49 (7465) 9260-0 Fax: +49 (7465) 9260-50 Email: info@stoma.de
Official Correspondent: Gunther Schanz
Device Name 1.
Trade Name: STOMA Bone Screw Common Name: Bone Screw
Classification 2.
The products are classified according following Device Names and Product Codes:
| Device: | Screw, Fixation, Intraosseous |
|---|---|
| Medical Specialty: | Dental |
| Product Code: | DZL |
| Regulation Number: | 872.4880 |
| Device Class: | 2 |
| Description acc. 21 CFR 872.4880: | |
| Subpart E -- Surgical Devices | |
| Sec. 872.4880 Intraosseous fixation screw or wire. | |
| (a) Identification. An intraosseous fixation screw or wire is a metal device intended to | |
| be inserted into fractured jaw bone segments to prevent their movement. | |
| (b) Classification. Class II. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
K051871
A01
Summary ¥1.4.doc | CALL CONSULT A - CLAIMER CLAIM L - LA LL - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L -
A . LE LEAR DEL PARTY
Date of Issue: 2005-06-30 | 1 01 2
Page |
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None of the R. Local and any of
C MEDAGENT Gmth & Co. KG | A MOLECON R WARREND - BULLET BELL | I |
1
STOMA Bone Screws
stoma. Storz am Mark
GmbH
510(k) Notification
Description of the Device 3.
Indication for Use 3.1.
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.
3.2. Properties
The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.
Substantial Equivalence Comparison 4.
STOMA Bone Screws are substantially equivalent to other legally marketed bone screws from different manufacturers, e.g. OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760) and/or Synthes (USA) 1.3 Craniofacial Srews (K021850).
5. Biocompatibility
All requirements of biocompatibility are meet through the composition of the used material. The used titanium alloy is also used in many other medical devices, especially implants.
Compared with competitors devices, STOMA Bone Screws are made out of substantially equivalent or identical material.
ં. Sterilization by User
STOMA Bone Screws are delivered in non-sterile conditions. The user may sterilize these devices by using a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes.
7. Conclusion
Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that STOMA Bone Screws are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
Date of Issue: 2005-06-30
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
Storz am Mark GmbH C/O Mr. Franz Menean Managing Director Medagent GMBH & Co. KG Griesweg 47 Muehlheim GERMANY 78570
Re: K051871
Trade/Device Name: STOMA BONE SCREW Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous fixation screw or wire Regulatory Class: II Product Code: DZL Dated: August 22, 2005 Received: August 30, 2005
Dear Mr. Menean:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section 910(x) premained instally equivalent (for the indications referenced above and nave decemblicated the acresed predicate devices marketed in interstate for use stated in the encrosure to regally manatical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Ecolors of the Ecoderel Good. Drug commerce prior to May 28, 1970, the chaeanters with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance water approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P and Cosmetic Act (Act) that do not require approvide on trols provisions of the Act. The
You may, therefore, market the device, subject to the generation, lightestion, ligh You may, merelore, market the de rece, booject of the more
general controls provisions of the Act include requirements for annual registration disassed general controls provisions of the Fiel herdares and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) not existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such adultional controlist Extremig and of of 998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 Parts of be found in the Code of I ederal regaranting your device in the Federal Register.
3
Page 2 - Mr. Menean
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a substitive requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a deciclimation administered by other Federal agencies. You must or any Federal statules and regulations daministered or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, mendants, was its requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fart on ); good manation (21 CFR Part 200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 14 CF forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (occions 55 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to 1egal This letter will anow you to begin mancemis requiredice of your device to a legally
premarket notification. The FDA finding of substantial equivaliae and thus, permits vour premarket notification. The PDA imaling of substanced on this, 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
r the latest of the support on 101 and 14 for the regulation entitled If you desire specific advice for your ac no not on success note the regulation entitled, the regulation entitled, the move obtain contact the Office of Compliance at (210) 217 - 10 (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obt "Misbranding by reference to premarkst notheation" (er the Act from the Division of Small other general information on your responsion its toll-free number (800) 638-2041 or 14 Manufacturers, International and Consumer rebets http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K_05187 |
Device Name: STOMA Bone Screw
Indications for Use:
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of surgery implanted bone blocks during the augmentation process and / or in combination with transplantou bette brome the oral cavity and maxillomandibular surgical field.
Prescription Use YES_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punds
", Asion Sign-Off) Chision Sign-Om)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:_
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