(81 days)
Not Found
No
The summary describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support, which is a therapeutic function.
No
The device is described as an internal support implant for a surgical intervention, not for diagnosing a condition.
No
The device description clearly states it is an "implant" and includes "corresponding instrumentation to facilitate insertion," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The MBAResorb Implant is an implantable device used in vivo (inside the body) to provide structural support during surgery. It is a surgical implant, not a diagnostic tool that analyzes biological samples.
The description clearly states its function as an internal support during surgery for flat foot, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBJ, MJW
Device Description
The MBARsaro Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.
Materials: Poly L-Lactide (PLLA)
Shelf Life: This product will be labeled with a shelf life of 1 (one) year
Function: The system functions as a temporary, supplemental support to primary interventions in the treatment of flat foot.
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
Not Found
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.
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
SEP -- 6 2005
APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS
For
MBAResorb Implant
1. Submitter: Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Suite 180 Carlsbad, CA 9201 1
Contact Person:
John G. Spampinato, V. P., Q.A Kinetikos Medical, Inc. 6005 Hidden Valley Road Suite 180 Carlsbad, CA 92011 FAX (760) 448 1739 (760) 448 1706
Date Prepared: Aug 15, 2005
MBAResorb Implant 2. Trade Name: Subtalar Maxwell-Brancheau Arthroereisis Implant Common Name: Classification Name: O Orthopedic Foot Implant
- Predicate or legally marketed devices which are substantially equivalent 3. -KMI Subtalar MBA Orthopedic Foot Implant (K960692 cleared Jul 23, 1996) -Linvatec BioScrew Absorbable Interference Screw (K973758 cleared Feb 27, 1998)
4. Description of Device
The MBARsaro Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.
Materials: Poly L-Lactide (PLLA)
Shelf Life: This product will be labeled with a shelf life of 1 (one) year
Function: The system functions as a temporary, supplemental support to primary interventions in the treatment of flat foot.
-
- Intended Use The MBAResor Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing'.
Use of this implant is contraindicated for use in patients with the following conditions:
- Intended Use The MBAResor Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing'.
-
Active local infection / any evidence of infection �
-
Allergic reaction to foreign bodies .
-
Poor or insufficient bone stock ●
-
The presence of any clinica! or functional abnormalities that would . preclude the potential of achieving a good result for the patient
-
Other conditions that may place the patient at risk (physiologically) .
Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the MBA Resorb Implant and other I horesrobable systems currently being marketed which would adversely affect the use of the product. The MBA Resorb Implant employs the same basic mechanical features as the predicate, legally marketed device specified in section I, but the material is reabsorbed by the body. The poly l-lactic acid material has been in use in a variety of other implant device applications for over 10 years.
- 1 = Soft Tissue Procedures, Foot and Ankle Clinics, Volume 8, Number 3, (503-520) Sept 2003 David F. Sitler, MD, S. Josh Bell, MD
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
Public Health Service
SEP - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John G. Spampinato Vice President, Quality Assurance Kinetikos Medical, Incorporated 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92011
Re: K051611
Trade/Device Name: MBAResorb Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBJ, MJW Dated: June 14, 2005 Received: June 17, 2005
Dear Mr. Spampinato:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) promatics is substantially equivalent (for the indications referenced above and nave uctoringed the actreed predicate devices marketed in interstate for tise stated in the encrosule) to regally manatist date of the Medical Device Amendments, or to commerce prof to May 20, 1976, the enactions of the Federal Food. Drug. devices that have been reclassified in accordance was a proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosmelle Act (Act) that do not require approvince approvisions of the Act. The You may, ulefelove, market the devices, soojoor of the more in the manual registration, listing of the general controls provisions of the Feet mensions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FD be found in the Code of Peachar Registerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issuation of a basedants with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmansir ana Journistered by other Federal agencies. You must or any Federal Statutes and regulations daministered of not limited to: registration and listing (21 let comply with an the Act 3 requirements, new 801); good manufacturing practice requirements as set a CFK Part 807), adomig (21 CFR Part 800); and If applicable, the electronic (200); and If applicable, the electronic (200 form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Mr. John G. Spampinato
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough maing of substantial equivalence of your device to a legally prematice notineation: "The Pressification 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 If you desire specific advice 10. Jour 2017 -0120. Also, please note the regulation entitled, Connact the Office of Companies market notification" (21CFR Part 807.97). You may obtain Whisoranding of reference to presessibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Z
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Kinetikos Medical MBAResorb_Implant Device Name:
Indications For Use:
The MBAResorb Implant is indicated as an internal support to primary surgical The MBAReson Implant is Internal oupport of Philiary of Providing structural support at minimum during
interventions in the treatment of flat foot, providing structural suppo the first three months of healing.
Prescription Use _ X (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)
| (Division Sign-Off) | Page 1 of 1 |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K051611 |