(51 days)
Not Found
No
The description focuses on the mechanical properties and design of the plates and screws, with no mention of AI or ML capabilities.
Yes
The device is indicated for the repair of osteotomies and fractures, and arthrodesis, which are therapeutic interventions.
No
The device description clearly states its purpose is for "fixation plates and screws" used in the "repair of osteotomies and fractures," which are therapeutic/treatment functions, not diagnostic.
No
The device description explicitly states that the Maxlock System includes physical components such as fixation plates and screws made from Titanium alloy. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description: The MaxLock Small Bone System is a collection of plates and screws made of titanium. These are implanted into the body to repair bones.
- Intended Use: The intended use is to repair osteotomies and fractures and perform arthrodesis of bones in the hands, wrists, feet, and ankles. This is a surgical procedure performed inside the body.
The description clearly indicates that this is a surgical implant used for structural support and repair within the body, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The MaxLock Small Bone System is indicated for the repair of osteotomies and fractures of:
- Phalanges of the hands and feet.
- Metacarpals and metatarsals.
- Carpals and tarsal bones.
- The wrist and ankle and,
- Arthrodesis of the hands, wrists, foot and ankle.
Product codes
HRS
Device Description
The Maxlock System includes ten (10) fixation plates and 38 screws. Plates vary in size, number of holes and in configuration. Screws vary in size by diameter and length.
All plates and screws in the Maxlock System are made from Titanium Ti-6Al-4V ELI Alloy. This material conforms with ASTM F-136 Standard Specification for Wrought Titanium 6AI-4V ELI Alloy for Surgical Implant Applications.
The unique X-Cross Profile and curvature of the plates are intended to better match the patients' anatomy. All edges are beveled to minimize wear on surrounding soft tissue and ligaments. The plates are contourable during surgery, to allow a better fit to the profile of bone. Plate holes are counter-sunk to lower the profile of the screw head and help minimize wear on the surrounding soft tissue and ligaments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands and feet, wrist and ankle
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
FEA's confirm that the MaxLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
MAY 2 7 2005
ﺑ
510(k) Premarket Notification
MaxLock™ Small Bone System
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 3975 Embassy Parkway Akron, Ohio 44333 Phone: (866) 904-3549 Fax: (352) 371-3932
| Contact Person: | Edward A. Kroll
Representative Consultant for
OrthoHelix Surgical Designs, Inc. |
| ----------------- | --------------------------------------------------------------------------------------- |
|---|
March 31, 2005 Date Prepared:
Name of Device
MaxLock ™ Small Bone System
Common or Usual Name
Fixation Plates and Screws
Classification Name
Single/Multiple Component Metallic Fixation Appliances and Accessories
Predicate Devices
DePuy 100 Tubular Plate (K920738) KLS Martin Hand Plating System (K040598)
Intended Use
Repair of osteotomies and fractures of small bones in the hand and feet
Device Description
The Maxlock System includes ten (10) fixation plates and 38 screws. Plates vary in size, number of holes and in configuration. Screws vary in size by diameter and length.
1
KC50 868
2/2
MaxLock™ Small Bone System
All plates and screws in the Maxlock System are made from Titanium Ti-6Al-4V ELI Alloy. This material conforms with ASTM F-136 Standard Specification for Wrought Titanium 6AI-4V ELI Alloy for Surgical Implant Applications.
The unique X-Cross Profile and curvature of the plates are intended to better match the patients' anatomy. All edges are beveled to minimize wear on surrounding soft tissue and ligaments. The plates are contourable during surgery, to allow a better fit to the profile of bone. Plate holes are counter-sunk to lower the profile of the screw head and help minimize wear on the surrounding soft tissue and ligaments.
Performance Data
FEA's confirm that the MaxLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.
MAY 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthohelix Surgical Designs, Inc. C/o Mr. Edward A. Kroll Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141
Re: K050868 Trade/Device Name: Maxlock™ Small Bone System_ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 4, 2005 Received: April 6, 2005
Dear Mr. Kroll:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ase suated in the encrease) of the enactment date of the Medical Device Amendments, or to conninered pror to they 2011 de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may or subject to basil as a suble to and the 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 r reaso be aar made a determination that your device complies with other requirements of the Act that I Dr Hao Intact a and regulations administered by other Federal agencies. You must or any I 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
3
Page 2 - Mr. Edward A. Kroll
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maing of substantial equivalence of your device to a legally premaired 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 If you desire specific acrice for Jour as 10 (240) 276-0120. Also, please note the regulation entitled, comaci the Office of Complanes at (21 t 7 = 1 = 1 = 1 = 1 = 1 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Stipt. Clude
Dr. Miriam C. Provost, Ph.D.
Provost. F Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: MaxLock™ Small Bone System
Indications for Use:
The MaxLock Small Bone System is indicated for the repair of osteotomies and fractures of:
- Phalanges of the hands and feet. .
- Metacarpals and metatarsals. .
- Carpals and tarsal bones. .
- The wrist and ankle and, .
- Arthrodesis of the hands, wrists, foot and ankle. .
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of (
Stypt Rurda
(Division Division of General, Restorative, and Neurological Devices
510(k) Number ... KOSO 868