(154 days)
Not Found
No
The device description and intended use focus on a physical implant for subtalar joint stabilization, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as treating a medical condition ("hyperpronated foot") and is designed to correct anatomical displacement and allow normal joint motion, which are therapeutic functions.
No
Explanation: The device is described as a spacer for stabilization of the subtalar joint and an implant, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly states the device is made of Ti-6AI-4V ELI and is an implantable spacer, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "spacer for stabilization of the subtalar joint" and is used to treat a "hyperpronated foot." This describes a device used in vivo (within the body) for a therapeutic purpose.
- Device Description: The device is described as being made of Ti-6AI-4V ELI and is an "implant." This further confirms it's an internal medical device.
- Anatomical Site: The device is used in the "subtalar joint," which is a part of the human anatomy.
- Intended User / Care Setting: The intended user is a "physician" in a "surgical setting," which aligns with the use of an implantable device.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The KMI Subtalar MBA System™ does not fit this description.
N/A
Intended Use / Indications for Use
The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion out blocking excessive pronation and the resulting sequela.
The Subtalar MBA System is indicated for use in the treatment of the hyperpronated foot displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela
Severely pronated foot Walking intemperance Calcaneal stance position greater than 5° Manually correctable deformity Mid-tarsal breech (arch pain) Forefoot varus greater than 10°
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The KMI Subtalar MBA System™ will be offered in Ti-6AI-4V ELI. It will be available in a range of diameters and will be cannulated for precise location of the implant. Initially, a range of four diameters will be made available in 15mm lengths. All four diameters (6,8,10, and 12mm) are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Substantial Equivalence for the KMI Subtalar MBA System™ may be found in comparison with devices from a number of manufactures. Subtalar joint implant systems in general have been used for many years, and the clinical performance is well known and documented in the body of this submission.
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of stabilizing the subtalar joint for correction of flatfeet and associated midfoot adjustments has over 20 years of clinical cvaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.
No performance standards applicable to the Subtalar MBA implant have been established by the FDA. However, the titanium alloy 6AL-V ELI alloy used to manufacture the KMI implant meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84). Additionally, the titanium alloy used mects the chemical and mechanical requirements of the voluntary standards established by the American Society for Testing and Materials (ASTM 136-84, B 800-74).
The KMI Subtalar MBA System™ meets the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design of implants for medical application. The implant serves to function as the device listed above, and will have a higher loading capacity because it is made from titanium rather than polyethylene like the devices from many other orthopaedic companies being offered in the market.
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
JUL 23 1998
Image /page/0/Picture/2 description: The image shows the logo for Kinetikos Medical Incorporated. The words "Kinetikos Medical" are stacked on top of the letters "KMI" in a large font. The word "Incorporated" is below the letters "KMI".
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Subtalar MBA System™
Screening for Safety and Effectiveness Information
For Release Upon Request Only
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name / Contact:
- Company: KMI (Kinetikos Medical Inc.) 3950 Sorrento Valley Blvd San Diego, Ca 92110
- Regulatory Affairs Department Contact: KMI 3950 Sorrento Valley Blvd San Diego, Ca 92110 (619) 558-2233
Establishment Registration Number: 2028840
Classification Name: Smooth or Threaded Bone Stabilization Device Common Used Name: Subtalar Arthorisis Implant Subtalar MBA System™ Trade Proprietary Name:
The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is HWC ( Product Code: HWC ) , and KMI submits this application under this designation.
1
Image /page/1/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the letters KMI in a large, bold font. Above the letters, the words "KINETIKOS MEDICAL" are written in a smaller font. Below the letters, the word "INCORPORATED" is written in a smaller font.
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Subtalar MBA System™
Performance Standards:
No performance standards applicable to the Subtalar MBA implant have been established by the FDA. However, the titanium alloy 6AL-V ELI alloy used to manufacture the KMI implant meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84). Additionally, the titanium alloy used mects the chemical and mechanical requirements of the voluntary standards established by the American Society for Testing and Materials (ASTM 136-84, B 800-74).
Package and Labeling:
·
Draft Package labeling has been developed and enclosed in Section 2 attachments. A draft package insert has also been developed and enclosed in Section 2 for your review and consideration.
System Description:
The KMI Subtalar MBA System™ will be offered in Ti-6AI-4V ELI. It will be available in a range of diameters and will be cannulated for precise location of the implant. Initially, a range of four diameters will be made available in 15mm lengths. All four diameters (6,8,10, and 12mm) are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
Indications for Use:
The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion out blocking excessive pronation and the resulting sequela.
2
Image /page/2/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the words "KINETIKOS MEDICAL" in a sans-serif font at the top. Below that is the large letters "KMI" and below that is the word "INCORPORATED".
Comments of the comments of the comments of the comments of the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Subtalar MBA System™
Substantial Equivalent Devices:
This product is substantially equivalent in design, composition and/or function to another orthopedic implant device manufactured and approved for market.
Wright Medical:
.
K792670
The KMI Subtalar MBA System™ meets the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design of implants for medical application. The implant serves to function as the device listed above, and will have a higher loading capacity because it is made from titanium rather than polyethylene like the devices from many other orthopaedic companies being offered in the market.
3
Image /page/3/Picture/1 description: The image shows the logo for Kinetikos Medical Incorporated. The logo features the letters "KMI" in a large, bold font. Above the letters, the words "KINETIKOS MEDICAL" are printed in a smaller font. Below the letters, the word "INCORPORATED" is printed in a smaller font.
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Subtalar MBA System™
Instrumentation:
Subtalar MBA System™ instrumentation used for the preparation and KMI insertion of the Subtalar implant is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All Subtalar MBA System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
Product Sterilization:
KMI will supply all instruments and implants Non-Sterile. Non-Sterile implants are packaged in "clean only" condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/ro-sterilization guideline.
Summary:
Substantial Equivalence for the KMI Subtalar MBA System™ may be found in comparison with devices from a number of manufactures. Subtalar joint implant systems in general have been used for many years, and the clinical performance is well known and documented in the body of this submission.
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of stabilizing the subtalar joint for correction of flatfeet and associated midfoot adjustments has over 20 years of clinical cvaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.
4
the setting... still
•
ி கோல்லில் உள்ள விளைக்கழகத்திற்குற
KM
이 대한민국 문
Image /page/4/Picture/23 description: The image shows a close-up of some handwritten text. The text appears to be in cursive and is written in black ink on a white background. The letters are somewhat difficult to read due to the style of handwriting and the close-up view.
5
Image /page/5/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is black and white and features the text "KINETIKOS MEDICAL" in a sans-serif font. Below this text is the large letters "KMI" in a bold, blocky font. Underneath the letters is the word "INCORPORATED" in a smaller font.
510(k) Application Product: Subtalar MBA System™
Draft Package Label:
Draft Package Label
| KMI Subtalar MBA Implant | Non-sterile |
|---|---|
| Catalog #05-0110 | |
| Diameter: | 10 mm |
| Length: | 15 mm |
| Quantity: | 1 |
| Material: | Titanium Alloy (6AL-4V, ELI) |
| Manufactured For: | KMI |
| 3950 Sorrento Valley Blvd. | |
| San Diego, Ca 92121 |
Warning: Federal Law (USA) restricts this product to sale by or on the order of a physician.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
| PN Xs Rev A | KMI, 1996 | Subtalar MBA System™ |
|---|---|---|
| ------------- | ----------- | ---------------------- |
FAGSIMILE: (619)$58-0838 3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: (619)558-2233
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Image /page/6/Picture/0 description: The image shows the logo for Kinetikos Medical. The logo is black and white and features the letters KMI in a large, bold font. Below the letters is the word INCORPORATED in a smaller font.
510(k) Application Product: Subtalar MBA System™
Draft Package Insert:
Package Insert for Subtalar MBA System™
Caution:
U.S. Federal Law restricts this product to sale on or by the order of a physician.
-
The surgeon must be thoroughly knowledgeable of the mechanical and metallurgical 1 . limitations of metallic surgical implants
-
The patient should be adequantly instructed . Postoperative sabley's ability and 2 healing. The petent mas be meaning been in promote of the substant rapidate and bata
physical activity and full wear were of the intractor in promoure fallar
The petent shou normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing -
Removal of the implant after position correction or healing. Metallic implants can loosen, 3. fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even aller healing perseasing when stations whene to remove the under arefully
wengin the rate bearther when server on emove the worden.
It the patiently adversions in t -
Inchant for the englished for feal simple and resident support and and the management of the manufactures in the manufactures in the learnies and clay of 4. prevent healing and re-alignment to occur
-
stabilization is complete, forces continue to be placed on the implant, and fullure may occur Even when the re-alignment and 5
-
Safety Presently of the inplus as is extently important The potential for selsiador
stabilization devices cannot withstand activity levels equal to those placed on normal, healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing
7
Image /page/7/Picture/0 description: The image shows the logo for Kinetikos Medical. The logo is in black and white and features the letters KMI in a large, bold font. Below the letters is the word "INCORPORATED" in a smaller font.
510(k) Application Product: Subtalar MBA System™
Draft Package Insert Cont'd:
Implants can break when subjected to the increased loading associated with delayed 2. stabilization o cealianean section comment coment may also contribute to early fatigue fathere (Patients should be fully informed of risks of implant failure)
-
Correct handling of the implant is extremely important. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant
-
Mixing metals can cause corresion. Dissimilar metals in contact, such as titanium implants used with stainless steel bone plates, accelerate the corrosion process of stainless steel and rapid attack occurs. The presence of corrosion process of stamless steel and rapid The presence of corrosion accelerates fatigue fracture of the implant. attack occurs. Internal stabilization and/or fixation devices, such as implans, plates and screws which come in contact, must be made from like or compatible metals.
An ex-planted implant should never be re-5. Surgical implants must never be reused implanted
SPECIFIC INDICATIONS FOR USE:
The Subtalar MBA System is indicated for use in the treatment of the hyperpronated foot displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela
Severely pronated foot Walking intemperance Calcaneal stance position greater than 5° Manually correctable deformity Mid-tarsal breech (arch pain) Forefoot varus greater than 10°
The Subtalar unpaint is contraince for use in patients with the following conditions. Active local infection (Any evidence of infection) Metal sensitivity or allergic reaction to foreign bodies. Other conditions that may place the patient at risk (Physiclosegoally)
When quality of bone stock peovents secure seating of the molant preclude the potential of achieving a good result for the patient
- PHONE :614.558
(619)558-0838
FACSIMILE
8
Image /page/8/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the letters "KMI" in a large, bold font. Above the letters, the words "KINETIKOS MEDICAL" are printed in a smaller font. Below the letters, the word "INCORPORATED" is printed in a smaller font.
510(k) Application Product: Subtalar MBA System™
Draft Package Insert Cont'd:
Possible Ar
The following in specific adverse There do not include all udverse effects which can oveur with explained to the patient. but are important considerations particular to metallic internal surgery in general, General surgical risks should be explained to the patient prior to stabilization devices. surgerv
- Infoction 1.
- Pain, disconnfort, or abnormal sensations due to presence of the implant 2
- t and considerity, or allergie reaction to a foreign body
Migration of the implant, locscoing of the implant నా - ব .
- Delayed correction in alignment ഗ
- Decrease in bone density due to stress shielding 6.
- Bursitis 7
Possibl
-
-
- ర్థాన్ని ప్రభుత్ reatigh the subtalar joint. 3.
-
- Fallure to c
Packaging:
Each of the KMI Subtalar Implants should be received in an intect package: Damaged packages or products should not be used and should be returned to KMI.
Sterilization:
Unless supplied sterile and clearly listeled as such, all Subtalar implants must be steam Oness supplied surgery. KMI Subtalar maplants and instruments may be steam sterilized by the hospital using the following process parameters.
Method: Steam 彩 Cycle: Gravitv Temperature: 270 F (132 C) Exposure Time: 30 minutes
charging material prior to sterilization. Only sterite implants and Remove all pr instruments removed from the surgery. Immediately re-serthire all implants and surgical impaints.
PN XXXXXXXXXXXXX, Rev A Manufactured & Distributed by KMI, Inc. 3950 Sorrento Valley Blvd San Diego, CA 92121 KM. 1996
CALIFORNIA 92121 TELEPHONE (619) 558-2233 FACSIMILE (619) 558-0838
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Image /page/9/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo features the letters "KMI" in a large, bold font. Above the letters, the words "KINETIKOS MEDICAL" are printed in a smaller font. Below the letters, the word "INCORPORATED" is printed in a smaller font.
510(k) Application Product: Subtalar MBA System™
Packaging:
All packaging will be of a sufficient design and material quality to provide protection from physical damage during transportation and storage. Typical packaging used for such applications are medical grade peel packs. blister packs, pouches, boxes with foam compartments, clear plastic tubes with end caps and fiberboard shippers and cartons.
The packaging offered is equivalent to that which is used with the predicate devices listed within this document, and in most cases is supplied by the same manufacturers that supply major orthopaedic companies
Currently, KMI is considering medical grade packs and/or plastic tubes for the individual packaging of the Subtalar implants. The package or tube will be sealed which will provide for the integrity and security of the product The implants will be provided non-sterile and labeled as such
Image /page/9/Picture/7 description: The image shows the word "FACSIMILE" and the phone number (619) 558-0838. The word "FACSIMILE" is written in a bold, sans-serif font. The phone number is written in a smaller, regular font. The image is black and white and appears to be a scan of a document.
10
Image /page/10/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo features the words "KINETIKOS MEDICAL" in a smaller font above the letters "KMI" in a much larger font. Below the letters "KMI" are the words "INCORPORATED" in a smaller font.
510(k) Application Product: Subtalar MBA System™
Promotional Material:
This system's promotional material has not been developed. However, all promotional material will be developed within the guidelines set fourth by the FDA as they pertain to these products
KMI's Subtalar MBA System'™ promotional material will be similar and in most cases more informative then that material which is supplied with the predicate devices listed within this notification
A draft protocol and catalog listing is provided on the next page for reference, however these items are currently under review and may change prior to distribution of product.
Image /page/10/Picture/7 description: The image shows the address and phone number of an organization. The address is 3950 Sorrento Valley Blvd, San Diego, California 92121. The telephone number is (619) 558-2233 and the facsimile number is (619) 558-0838.