(51 days)
Not Found
No
The device description and intended use focus on a physical implant and its mechanical function, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint, which involves treating a medical condition and restoring normal function.
No
The Biopro subtalar implant is designed to treat conditions like hyperpronated foot and flat foot by surgically stabilizing the subtalar joint. It is a therapeutic implant, not a device used to identify or diagnose a condition.
No
The device description explicitly states it is a combination of three components made of titanium alloy and UHMW Polyethylene, which are hardware materials.
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 Biopro subtalar implant is a physical implant made of titanium and UHMW Polyethylene that is surgically placed in the subtalar joint.
- Intended Use: The intended use is to treat and stabilize the subtalar joint by blocking excessive pronation. This is a therapeutic intervention, not a diagnostic test.
The device is a surgical implant used for treatment, not for analyzing biological samples to diagnose a condition.
N/A
Intended Use / Indications for Use
The Biopro subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Conditions include:
Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopedic treatment (orthodics) Tarsal coalitions Painfully flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability
Product codes
HWC
Device Description
The Biopro Sub-talar Implant is a combination of three components. Two components made of titanium allow and one component made of UHMW Polyethylene. It will be provided in a range of diameters, including 8mm-12mm in diameter. The device will be cannulated for precise implantation. The device is implanted using a standard 0.125" square driver which is cannulated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint, foot
Indicated Patient Age Range
children and adolescents
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)
KMI Subtalar MBA System™ K960692, Kalix® implant K001231
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Biologically Oriented Prostheses. The logo has the word "BIOPRO" in a rectangular box, with the first half of the O being white and the second half being black. Below the box, it says "Division of Implant Manufacturing & Testing, Inc."
SEP = 8 2004
17 Seventeenth St. Port Huron, MI 48060 (810) 982-7777 Fax (810) 982-7794
Fax (810) 982-7794
page 1 of 2
510K Summary of Safety and Effectiveness
Date Prepared: Friday, November 21, 2003
Company name and contact:
Biopro, Inc. 17 17th Street Port Huron, MI 48060 (P)810-982-7777) (F)810-982-7794
Contact Person : David Mrak, Director of Product Development
Proprietary Name: Biopro Sub-talar Implant
Common Name: Flatfoot Implant
Classification name: Screw, Fixation, Bone (per CFR section 888.3040)
Predicate Device:
The Biopro Sub-talar Implant is substantially equivalent in design, composition and function to other orthopedice screws manufactured and approved for maket such as: KMI Subtalar MBA System™ K960692 and the Kalix® implant K001231
Device Description:
The Biopro Sub-talar Implant is a combination of three components. Two components made of titanium allow and one component made of UHMW Polyethylene. It will be provided in a range of diameters, including 8mm-12mm in diameter. The device will be cannulated for precise implantation. The device is implanted using a standard 0.125" square driver which is cannulated.
Intended use:
The Biopro Subtalar Implant will be used on indications that are common with presently marketed devices. The primary indications for use of the Biopro Subtalar Implant is as a spacer for stabilixation of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
1
Bossible Adverse Effects
K041936
page 20 of 2
The following are specific adverse effects which should be understood by the surgeon and rric following are spoolins these do not include all adverse effects which can occur with surgery in general, but are important considerations particular to metallic internal stabilization devices. General surgical risks should be explained to the patient prior to surgery.
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- Infection
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- Pain discomfort or abnormal sensations due to presence of the implant
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- Metal sensitivity or allergic reaction to a foreign body
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- Migration of the implant loosening of the implant
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- Delaved correction in alignment
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- Decrease in bone density due to stress shielding
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- Bursitis
Packaging:
Each of the BioPro Subtalar Implants should be received in an intact package: Damaged packages or products should not be used and should be returned to Biopro.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Mr. David Mrak Director of Product Development Biopro, Inc. 17 Seventeenth Street Port Huron, Michigan 48060
Re: K041936 Trade Name: Biopro Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 12, 2004 Received: July 28, 2004
Dear Mr. Mrak :
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. David Mrak
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 premaince 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Mcllhaney
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
4
K04/1936
Indications For Use
The Biopro subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Conditions include:
Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopedic treatment (orthodics) Tarsal coalitions Painfully flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability
(Division Sign-Off) Division of General, Restorative And Neurological Devices
510K Number_ Ko4193C
Mark N. Milliken
Division of General, Restorative, and Neurological Devices
510(k) Number K041936
Prescription Use X (Per 21 CFR 801.109)
Or
Over-the-Counter___