(44 days)
Not Found
Not Found
No
The device description focuses solely on the physical characteristics and materials of bone screws, with no mention of software, algorithms, or any computational capabilities that would suggest AI/ML.
Yes
The device is intended for internal fracture fixation, which is a therapeutic intervention to treat bone fractures.
No
Explanation: The device, Osteo Small and Mini Bone Screws, is described as being "intended for internal fracture fixation of small bones." This indicates a therapeutic or interventional purpose, not a diagnostic one.
No
The device description clearly details physical hardware components (bone screws made of stainless steel with specific dimensions and features), indicating it is not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that these are bone screws made of stainless steel, intended for internal fracture fixation. They are physical implants used to stabilize bones.
- Intended Use: The intended use is for "internal fracture fixation of small bones." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided describes a medical device used in surgery, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Small Cortex Screws:
The Osteo Small Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread with three cutting grooves. The thread diameter measures 2.5mm, and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 5mm in diameter. The Osteo Small Cortex Screws are available in lengths from 6mm to 40mm.
Mini Cortex Screws:
The Osteo Mini Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and are available either with or without a self tapping thread on the self tapping screws features one cutting groove. The thread diameter measures 1.5mm, and the root diameter measures 1.0mm. These bone screws have a conical head underside with a cross slot. The head measures 2.5mm in diameter. The Osteo Mini Cortex Screws with a self tapping thread are available in lengths from 8mm to 22mm. The Osteo Mini Cortex Screws without a self tapping thread are available in lengths from 6mm to 20mm.
Small Cancellous Screws:
The Osteo Small Cancellous Screws are fabricated from ASTM F-138-92 stainless steel. The thread diameter measures 4.0mm. and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 6mm in diameter. The Osteo Small Cancellous Screws are available in lengths from 10mm to 60mm.
Mini Cancellous Screws:
The Osteo Mini Cancellous Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread. The self tapping thread features one cutting groove. The thread diameter measures 2.2mm, and the root diameter measures 1.1mm. These bone screws have a flat head with a cross slot. The head measures 3.0mm in diameter. The Osteo Mini Cancellous Screws are available in lengths from 8mm to 22mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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.
The Osteo Small and Mini Cortex Screws are substantially equivalent to the Synthes Small and Mini Cortex Screws. The Osteo Small and Mini Cancellous Screws are substantially equivalent to the Howmedica Small and Mini Bone 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
JUN 27 1997
K971778 16f2
Osteo Small and Mini Bone Screws
510(k) Premarket Notification
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO SMALL AND MINI BONE SCREWS
Submission Information Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Contact Person:
Regulatory Affairs Specialist
Donna S. Wilson
Date Summary Prepared:
Device Identification Proprietary Name:
Common Name:
anager
Classification Name and Reference:
May 13, 1997
Osteo Small and Mini Bone Screws
Bone Screws
Smooth Or Threaded Metallic Bone Fixation Fastener - 21 CFR §888.3040
Predicate Device Identification
The Osteo Small and Mini Cortex Screws are substantially equivalent to the Synthes Small and Mini Cortex Screws. The Osteo Small and Mini Cancellous Screws are substantially equivalent to the Howmedica Small and Mini Bone Screws.
Device Description
Small Cortex Screws:
The Osteo Small Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread with three cutting grooves. The thread diameter measures 2.5mm, and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 5mm in diameter. The Osteo Small Cortex Screws are available in lengths from 6mm to 40mm.
Mini Cortex Screws:
The Osteo Mini Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and are available either with or without a self tapping thread on the self tapping screws features one cutting groove. The thread diameter measures 1.5mm, and the root diameter measures 1.0mm. These bone screws have a conical head underside with a cross slot. The head measures 2.5mm in diameter. The Osteo Mini Cortex Screws with a self tapping thread are available in
1
Osteo Small and Mini Bone Screws
lengths from 8mm to 22mm. The Osteo Mini Cortex Screws without a self tapping thread are available in lengths from 6mm to 20mm.
Small Cancellous Screws:
The Osteo Small Cancellous Screws are fabricated from ASTM F-138-92 stainless steel. The thread diameter measures 4.0mm. and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 6mm in diameter. The Osteo Small Cancellous Screws are available in lengths from 10mm to 60mm.
Mini Cancellous Screws:
The Osteo Mini Cancellous Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread. The self tapping thread features one cutting groove. The thread diameter measures 2.2mm, and the root diameter measures 1.1mm. These bone screws have a flat head with a cross slot. The head measures 3.0mm in diameter. The Osteo Mini Cancellous Screws are available in lengths from 8mm to 22mm.
Intended Use
The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Osteo Small and Mini Bone Screws are available in non-sterile and sterile offerings.
Statement of Technological Comparison
The subject Osteo Small and Mini Bone Screws are substantially equivalent in materials (stainless steel), design (small and mini cortex and cancellous bone screws), and intended use (internal fracture fixation of small bones) to the predicate devices offered by Synthes and Howmedica.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings forming a human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna S. Wilson Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUN 27 1997
Re : K971778 Osteo Small and Mini Bone Screws Regulatory Class: II Product Code: HWC Dated: May 13, 1997 Received: May 14, 1997
Dear Ms. Wilson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
3
Page 2 - Ms. Donna S. Wilson
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for wa 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: "WARNING : attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations .
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Page 3 - Ms. Donna S. Wilson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Marie H. Schroeder, MS, PT
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K971278
Device Name: Osteo Small and Mini Bone Screws
Indications For Use:
}
The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
ડે
Nila R. Silveale
(Division Sign-Off) Division of Ceneral Restorative Devices 510(k) Number.