(85 days)
No
The summary describes a physical implant and its intended use, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is intended to treat a medical condition (hyperpronated foot, flat foot) and stabilize a joint, which are therapeutic functions.
No
The document describes an implantable device designed to treat hyperpronated foot and stabilize the subtalar joint, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical implant made of UHMWPE or Cobalt Chromium, intended to be surgically implanted. This is a hardware device, not software.
No, 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: The Futura Biomedical Subtalar Peg Implant is a physical implant designed to be surgically placed into the calcaneus bone of the foot. It acts as a mechanical spacer and stabilizer.
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot and subtalar joint instability) by physically modifying the joint structure.
This device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is 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. Examples include:
Flat foot treatment in children and adolescents
Congenital flat foot
Unsuccessful long term orthopaedic treatment (shoes, insoles ... )
Tarsal coalitions
Painful flat foot
Supple deformity in posterior tibial tendon dysfunction
Paralytic flat foot
Subtalar instability
This device is intended to be fixed with bone cement.
Product codes
MJW
Device Description
The Futura Biomedical Implant is a one-picce device made of UHMWPE or Cobalt Chromium with titanium plasma spray on the stem, intended to be implanted into the calcancus of the foot. The implant is designed in 13 sizes and two configurations. The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcancus of the 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)
K792670- Smith Subtalar Peg
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista. California 92081
Re: K033046
Trade/Device Name: Subtalar Peg Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MJW Dated: September 29, 2003 Received: September 29, 2003
Dear Ms. Focht:
This letter corrects our substantially equivalent letter of December 23, 2003.
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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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Page 2 - Ms. Louise M. Focht
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 Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education at its toll-free 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" (21CFR 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 Industry and Consumer Education 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,
Mark N. Mejkersons -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
1033046 510 (k) Number (If Known):_ Device Name: Subtalar Peg Implant
Indications for Use:
The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is 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. Examples include:
Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability
This device is intended to be fixed with bonc cement.
Prescription Use (Part 21 CFR 801 Subpant D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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...ion Siera Civi...
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DEC 2 3 2003 -
PAGE 1 of 3
510 (k) Summary
Summary of 510 (k) safety and effectivencss information upon which the substantial cquivalence determination is based:
December 22, 2003 Prepared: Futura Biomedical Applicant: 990 Park Center Drive Vista, CA 92081
760-599-1670 Telephone: Fax: 760-599-1675 Louise M. Focht Contact:
Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Predicate Device: Registration Number: Owner Operator Number: Subtalar Peg Implant Subtalar Peg Implant Class II Orthopedic
87 MJW K792670- Smith Subtalar Peg 2030833 9028319
Device Description:
The Futura Biomedical Implant is a one-picce device made of UHMWPE or Cobalt Chromium with titanium plasma spray on the stem, intended to be implanted into the calcancus of the foot. The implant is designed in 13 sizes and two configurations. The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
Indications for Use:
The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabalize the subtalar joint. It is 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. Examples include:
Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions
4
K03 3x46
Page 2 of 3
Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability
This device is intended to be fixed with bone cement.
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical STA-Peg implant.
Regulatory Class: II 87 MJW Product Code:
Table 1. Comparison of Futura Biomedical and Wright Medical STA-Peg Implant
| Item | Futura Product | Wright Medical Product |
|---|---|---|
| Product Name | Subtalar Peg Implant | STA-Peg Implant |
| Usc | Single use | Single use |
| Fixation | Stem in bone | Stem in bone |
| Constraint | Non constrained | non constrained |
| Material | UHMWPE or CoCr/CpTi | UHMWPE |
| Sizes | 5 sizes, two configurations (13 sizes) | 5 sizes |
| Indications for use | The Futura Biomedical Subtalar Peg | |
| Implant is intended to treat | ||
| hyperpronated foot and stabilize the | ||
| subtalar joint. It is 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. | ||
| Examples include: | ||
| Flat foot treatment in | ||
| children and adolescents | ||
| Congenital flat foot | ||
| Unsuccessful long term | ||
| orthopaedic treatment | ||
| (shoes, insolcs...) | ||
| Tarsal coalitions | ||
| Painful flat foot | ||
| Supple deformity in | ||
| posterior tibial tendon | ||
| dysfunction | ||
| Paralytic flat foot | ||
| Subtalar instability | ||
| This device is intended to be fixed | ||
| with bone cement | The STA-Peg implant is intended to | |
| treat hyperpronated foot and stabilize | ||
| the subtalar joint. It is 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. Examples | ||
| include: | ||
| Flat foot treatment in | ||
| children and adolescents | ||
| Congenital flat foot | ||
| Unsuccessful long term | ||
| orthopaedic treatment (shoes, | ||
| insoles...) | ||
| Tarsal coalitions | ||
| Painful flat foot | ||
| Supple deformity in posterior | ||
| tibial tendon dysfunction | ||
| Paralytic flat foot | ||
| Subtalar instability |
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PAGE 3 of 3
3
Similarities of the Futura Biomedical Subtalar Arthrorisis Implant and the Wright Medical STA-Peg Implant include:
Both devices are: intended for single use only; intended for surgical implantation longer Bour devices are: michood for single aco of the calcaneus of the foot, allowing normal than 50 days, both dovies are prinst excessive pronaton and resulting sequela; both Sublaial John model of industry standard materials are introduced in either uevices are made of made of marably sized; both devices have the same indications for use.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.