(77 days)
Not Found
No
The device description and intended use focus on a mechanical implant (screw) for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an implantable screw system intended to block excessive pronation in patients with flat foot, which directly treats a medical condition.
No
The device is described as an implantable screw system used for subtalar arthroereisis to block forward and medial displacement. It is a treatment device, not one that gathers information about a patient's condition for diagnosis.
No
The device description clearly states it is a threaded, cannulated, tapered screw made from stainless steel, which is a physical implant, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Normed® Pellegrin Calcaneus Stop Screw System is a surgical implant designed to be inserted into the calcaneus bone of the foot. Its purpose is to physically block excessive pronation and treat flat foot. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device used within the body for a therapeutic purpose, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Normed Pellegrin Calcaneus Stop Screw System Intended Use: is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Normed Pellegrin Calcaneus Stop Screws are threaded, cannulated, tapered screws. They designed to be inserted into the calcaneus bone of the foot for subtalar arthoroereisis. They are made from CrNiMO Stainless Steel for Surgical Implants (ASTM F138. ISO 58321). The implant is offered in 3 lengths - 25mm, 30mm and 35mm. The implants are provided non-sterile and singleuse only. The instruments are non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus bone of the foot
Indicated Patient Age Range
adult, children and adolescent 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)
Non-clinical testing demonstrated for the Normed Pellegrin Calcaneus Stop Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy.
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
§ 888.3040 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
510(k) Premarket Notification Normed Pellegrin Calcaneus Stop Screw K133035 page 1 of 3 '
510(k) Summary Pursuant to 21 CFR 807.92
General Company Information
DEC 1 3 2013
| Company Name: | Normed® Medizin-Tecknik GmbH |
|---|---|
| Company Address: | Ulrichstrasse 7 |
| D-78532 | |
| Tuttlingen, Germany | |
| Company Telephone: | +(011) 49 7461 93 43 0 |
| +(011) 49 7461 93 43 20 | |
| Contact: | Dalene Binkley, MS, RAC |
| FDC Services, LLC | |
| Regulatory Affairs Consultant | |
| Contact Address: | 1927 N. Arthur Drive |
| Columbia City, Indiana 46725 | |
| (260) 244-4189 | |
| Date: | December 9, 2013 |
| Device Trade Name: | Pellegrin Calcaneus Stop Screw |
| Common Name: | Subtalar Arthroereisis Implant |
| Classification Name: | Smooth & threaded metallic bone fixation |
| fasteners (21 CFR 888.3040) | |
| Class: | II |
| Product Code: | HWC |
| Predicate Device: | Trilliant Surgical Disco Subtalar Implant, |
| K111834 (cleared 12/6/11) | |
| Tornier Futura Angled Subtalar Implant, | |
| K033046 (cleared 12/23/03) |
1
510(k) Premarket Notification Normed Pellegrin Calcaneus Stop Screw
Multithread Vilex Cannulated Bone Screw, K014154 (cleared 3/18/02)
Device Description:
The Normed Pellegrin Calcaneus Stop Screws are threaded, cannulated, tapered screws. They designed to be inserted into the calcaneus bone of the foot for subtalar arthoroereisis. They are made from CrNiMO Stainless Steel for Surgical Implants (ASTM F138. ISO 58321). The implant is offered in 3 lengths - 25mm, 30mm and 35mm. The implants are provided non-sterile and singleuse only. The instruments are non-sterile and reusable.
The Pellegrin Calcaneus Stop Screw System Intended Use: is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents
Technological Characteristics:
The Pellegrin Calcaneus Stop Screw System are similar to legally marketed predicate devices listed previously. The screws share similar indications of use, are manufactured from similar materials and incorporate similar technological characteristics.
2
Performance Data (Nonclinical and/or Clinical):
Non-clinical testing demonstrated for the Normed Pellegrin Calcaneus Stop Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy.
| Device | Testing | Standard |
|---|---|---|
| Screws | The torsional properties of metallic bone screws | ASTM F543-07 |
| The driving torque properties of metallic bone screws | ASTM F543-07 | |
| Press-in bending characteristics of medical bone screw | Custom Test |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the bird. The image is black and white and appears to be a scan or photocopy.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2013
Normed® Medizin-Technik GmbH % Dalene Binkley, MS. RAC FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733
Re: K133035
Trade/Device Name: Normed® Pellegrin Calcaneus Stop Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 11, 2013 Received: October 17, 2013
Dear Ms. Binkley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 -Dalene Binkley, MS, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald##Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133035
້າ:"ຄາ:":" ກົງ:" ກົງ:"
Device Name Normed Pellegrin Calcaneus Stop Screw
Indications for Use (Describe)
The Normed® Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward and medial displacement of the allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
..:
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.