(76 days)
Not Found
No
The summary describes a mechanical implant (screw) and associated instrumentation for bone fixation. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is a screw system used for fracture fixation and Slipped Capital Femoral Epiphysis (SCFE), which are intended to treat or alleviate a medical condition.
No
The device is described as a titanium implant fracture fixation screw system used for surgical fixation, not for diagnosing medical conditions.
No
The device is a titanium implant fracture fixation screw system, which is a physical hardware device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The I.T.S. Epiphysis Screw is a physical implant designed for fracture fixation and bone stabilization. It is surgically implanted into the body.
- Intended Use: The intended use clearly states it's for fracture fixation and bone screw fixation in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one performed on a sample outside the body.
Therefore, the I.T.S. Epiphysis Screw falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The I.T.S. Epiphysis Screw is used to stabilize a slipped capital femoral epiphysis and fracture fixation in the pelvis of large bones and large bone fragments. The system is not intended for spinal use.
The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,
Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.
The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire pin. Screws are available partially threaded in lengths from 50mm to 120mm in 5mm increments. A full complement of instrumentation is available to assist in placement. The screws are manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, large bones, large bone fragments, slipped femoral capital epiphysis, ankle, knee, femoral neck, tibial plateau, intercondylar femur, subtalar
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
Synthes 6.5mm Cannulated Screw (K021932), Howmedica Osteonics ASNIS III Cannulated Screw (K000080), Orthomet/Wright Medical Cannulated Screw (K862157), Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K903810), Zimmer MAGNA-Fx Cannulated Screw Fixation system, Richards/Smith Nephew Universal Cannulated Screw, DePuyAce ACE SCFE Screw
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
FEB * 4 2005
Section XII: 510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.
Autal 28.
Lassnitzhoehe A - 8301
AUSTRIA |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Epiphysis Screw |
| COMMON NAME: | Cannulated Bone Screw |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener
(see 21 CRF, Sec. 888.3040). |
| DEVICE PRODUCT CODE: | HWC |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | Synthes 6.5mm Cannulated Screw (K021932)
Howmedica Osteonics ASNIS III Cannulated Screw (K000080)
Orthomet/Wright Medical Cannulated Screw (K862157)
Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw
(K903810)
Zimmer MAGNA-Fx Cannulated Screw Fixation system
Richards/Smith Nephew Universal Cannulated Screw
DePuyAce ACE SCFE Screw |
| DEVICE DESCRIPTION: | The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw
with a cancellous thread that can be guided into a position via a
guidewire pin. Screws are available partially threaded in lengths
from 50mm to 120mm in 5mm increments. A full complement of
instrumentation is available to assist in placement. The screws are
manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II
surface. |
| INTENDED USE: | The I.T.S. Epiphysis Screw is used to stabilize a slipped capital
femoral epiphysis and fracture fixation in the pelvis of large bones
and large bone fragments. The system is not intended for spinal
use |
.i
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
FEB 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S. Implant-Technologie-SystemeGMBH Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K043410
Trade/Device Name: Epiphysis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 10, 2004 Received: December 10, 2004
Dear Mr. Al Lippincott:
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. Iisting 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.
2
Page 2 - Mr. Al Lippincott
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Sincerely yours,
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
I.T.S. Implant-Technology-Systems GmbH
chäftsführende Gesellschafterin: Dr
1081 69 4 11 1 STORE CONSTITUTION
Indications for Use
510(k) NUMBER: DEVICE NAME: EPIPHYSIS SCREW INDICATIONS FOR USE:
The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,
Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.
The system is not intended for spinal use.
Prescription Use
AND/OR Over-The-Counter-Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Section X
EN ISO 1349
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Comeral, Regenciality of CDRH, Office of Device Evaluation (ODE) Division and Neurological Dev