(89 days)
Not Found
No
The 510(k) summary describes a purely mechanical implant and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is intended to treat a medical condition (hyperpronated foot and stabilize the subtalar joint) and block excessive pronation and its resulting sequelae, which aligns with the definition of a therapeutic device.
No
The device is an implant designed to treat a medical condition (hyperpronated foot and stabilize the subtalar joint) by acting as a spacer, not to diagnose a condition.
No
The device description explicitly states it is a one-piece implant made of Titanium intended to be implanted into the foot, indicating it 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Futura Biomedical Arthrorisis Implant is a physical implant made of titanium that is surgically placed into the sinus tarsi of the foot. It directly interacts with the body's structure to treat a condition.
- Intended Use: The intended use is to treat hyperpronated foot and stabilize the subtalar joint by physically blocking excessive motion. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
# Intended Use / Indications for Use
The Futura Biomedical Arthrorisis 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
# Product codes (comma separated list FDA assigned to the subject device)
87 HWC
# Device Description
The Futura Biomedical Implant is a one-piece device made of Titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 sizes. 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
foot (sinus tarsi, subtalar joint)
# 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): 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.
[K001231](https://510k.innolitics.com/search/K001231) - The New Deal Kalix Implant
# 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
DEC 1 5 2003
PAGE 1 of 3
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
September 13, 2003 Prepared:
Futura Biomedical Applicant: 990 Park Center Drive Vista, CA 92081
760-599-1670 Telephone: 760-599-1675 Fax: Louise M. Focht Contact:
Subtalar Arthrorisis Implant Device Name: Subtalar Arthrorisis Implant Device Trade Name: Class II Device Classification: Orthopedic Reviewing Panel: 888.3040 Regulation Number 87 HWC Product Code: K001231 - The New Deal Kalix Implant Predicate Device: 2030833 Registration Number: 9028319 Owner Operator Number:
Device Description:
The Futura Biomedical Implant is a one-piece device made of Titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 sizes. 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 Arthrorisis 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
1
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
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the New Deal Kalix Implant.
Regulatory Class: II 87 KXE Product Code:
Table 1. Comparison of Futura Biomedical and New Deal Kalix Implant
| Item | Futura Product | New Deal Product |
|---|---|---|
| Product Name | Subtalar Arthrorisis Implant | Subtalar Arthrorisiss Implant |
| Use | Single use | Single use |
| Fixation | Screw | Screw |
| Constraint | Non constrained | non constrained |
| Material | Titanium 6AL-4V ELI | Titanium alloy and UHMWPE |
| Sizes | 6 sizes | 5 sizes |
| Indications for use | The Futura Biomedical Arthrorisis | |
| 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: | The New Deal Kalix 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 | Flat foot treatment in | |
| children and adolescents | ||
| Congenital flat foot | Congenital flat foot | |
| Unsuccessful long term | ||
| orthopaedic treatment | ||
| (shoes, insoles...) | Unsuccessful long term | |
| orthopaedic treatment (shoes, | ||
| insoles...) | ||
| Tarsal coalitions | Tarsal coalitions | |
| Painful flat foot | Painful flat foot | |
| Supple deformity in | ||
| posterior tibial tendon | ||
| dysfunction | Supple deformity in posterior | |
| tibial tendon dysfunction | ||
| Paralytic flat foot | Paralytic flat foot | |
| Subtalar instability | Subtalar instability | |
2
Kc32902 PAGE 3 of 3
Similarities of the Futura Biomedical Subtalar Arthrorisis Implant and the New Deal Kalix Implant include:
Both devices are: intended for single use only; intended for surgical implantation longer Bour de rioes are mices are placed into the sinus tarsi of the foot, allowing normal than 50 days, '60dr doviete are piess ve pronaton and resulting sequela; both Subtain John mode of industry standard materials, no new materials are introduced in either devices are mude of measa , baarably 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
DEC 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92081
Re: K032902
Trade/Device Name: Subtalar Arthrorisis Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 16, 2003 Received: September 17, 2003
Dear Ms. Focht:
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.
4
Page 2 - Ms. Louise M. Focht
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 (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. Mulkeran
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
5
KO32902 510 (k) Number (If Known): Device Name: Subtalar Arthrorisis Implant
Indications for Use:
The Futura Biomedical Arthrorisis 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
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*Labels: **Value: **
STOR Neurologuesi Devices Ausision of Concent. Restorative (पुगु-गहिए एकाडार)
for Mark N. Millerson
of General tetorative curological De rices