(63 days)
Not Found
No
The description focuses solely on the materials and mechanical components of a fracture fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is one that treats a disease or condition. This device is used to repair fractures, which is a structural repair rather than a therapeutic treatment.
No
Explanation: The device is described as a titanium implant fracture fixation system for repairing fractures, which is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation". It details the materials and types of plates and screws, which are physical hardware components.
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.
- Device Description: The I.T.S. FR.O.H. Calcaneus Repair System is a surgical implant used to fix fractures in the calcaneus bone. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to repair bone fractures, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the I.T.S. FR.O.H. Calcaneus Repair System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.
Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.
This system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, NDF, NDJ
Device Description
The I.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation across calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate (universal left and right in 2 sizes) is made from CP titanium according to ASTM F 67-00 and corresponding plate locking and self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed titanium according to ASTM F 136-02. The fully threaded 7.3mm Cannulated Cancelous Screw is in various lengths from 50 to 90mm in 5mm increment sizes and is also made from 6-4 alloyed titanium according to ASTM F 136-02. All titanium plates and screws are surface conditioned with a TIODIZE, Type II preparation
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus heel bone in the foot
Indicated Patient Age Range
The system can be used in both adult and pediatric patients.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
:
AUG 2 2 2005
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: | FR.O.H. Calcaneus Repair System |
| COMMON NAME: | Bone Plate & Cannulated Cancellous Bone Screw System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030)
Smooth or threaded metallic bone fixation fastener
(see 21 CFR, Sec. 888.3040) |
| DEVICE PRODUCT CODE: | HRS & HWC |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Synthes Locking Calcaneal Plates (K991407)
DePuy/Ace Calcaneal Peri-articular Plate (K993465)
Ace/DePuy Cannulated Cancellous Bone Screw (K903810) |
| DEVICE DESCRIPTION: | The I.T.S. FR.O.H. Calcaneus Repair System is a combination of
fracture reduction and alignment instrumentation with either
calcaneus plate and/or cannulated cancellous screw fixation across
calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate
(universal left and right in 2 sizes) is made from CP titanium
according to ASTM F 67-00 and corresponding plate locking and
self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed
titanium according to ASTM F 136-02. The fully threaded 7.3mm
Cannulated Cancelous Screw is in various lengths from 50 to
90mm in 5mm increment sizes and is also made from 6-4 alloyed
titanium according to ASTM F 136-02. All titanium plates and
screws are surface conditioned with a TIODIZE, Type II
preparation |
| INTENDED USE: | The I.T.S. FR.O.H. Calcaneus Repair System is used to stabilize a
inta-articular and/or extra-articular fracture(s) and/or osteotomy of
the calcaneus heel bone in the foot. |
| BASIS OF SUBSTANTIAL
EQIVLAENCE: | The I.T.S. FR.O.H. Calcaneus Repair System Calcaneal Plate is
substantially equivalent to the Synthes (K991407) and, DePuy/Ace
(K993465) plating systems.
The I.T.S. FR.O.H. Calcaneus Repair System Cannulated
Cancellous Screw is substantially equivalent to the DePuy/Ace
(K903810) cannulated screw system. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. FR.O.H. Calcaneus Repair System is shown to be safe
and effective for use in fracture fixation of the calcaneus heel bone
in the foot. |
1
510(k) Summary of Safety and Effectiveness Continued:
:
.
·
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and two curved lines representing its legs. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
I.T.S. Implantat-Technologie-Systeme GmbH Mr. Albert Lippincott, III U.S. Agent and official Correspondent for I.T.S. Implantat-Technologie-Systeme GmbH Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K051642
Trade/Device Name: FR.O.H. Calcaneus Repair System Regulation Number: 21 CFR 888.3030, 21 CRF 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: NDF, NDJ Dated: June 10, 2005 Received: June 20, 2005
Dear Mr. 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, 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 – Mr. Albert Lippincott III
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegin mainening of substantial equivalence of your device to a legally premarket hourication. The PDA mising of cassification 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 advisor at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to prenessponsibilities under the Act from the Division of Small other general information on your respenser 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,
Barbato Bocchino
tor
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FN 163060 F
hnology-Systems GmbH
Geschaftsfuhrende Geseilschafterin: Dr. Eva Ruprechter
Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 office@ils-implant.com
Indications for Use
510(k) NUMBER: DEVICE NAME: FR.O.H. Calcaneus Repair System INDICATIONS FOR USE:
The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.
Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.
This system is not intended for spinal use.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter-Use
(21 CFR 801 Subpart C)
ILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)