(157 days)
Not Found
No
The summary describes a system of titanium plates and screws for bone fixation and mentions manual surgical instruments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
Yes
The device is described as an "Ankle Trauma system" intended for "fixation of fractures, osteotomies, and non-unions" in various bones, which directly addresses medical conditions by restoring function or relieving symptoms.
No
The device is described as a system for fixation of fractures, osteotomies, and non-unions, comprised of plates and screws for internal fixation of bones and bone fragments. It is a surgical implant for treatment, not a device for diagnosing conditions.
No
The device description explicitly states it is comprised of titanium plates, bone screws, and manual surgical instruments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone." This describes a surgical implant used to stabilize bones within the body.
- Device Description: The description details "titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments" and "bone screws." These are components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.
Materials:
Titanium alloy (Ti 6Al 4V ELI) per ASTM F136
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, and other small bones
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)
Nonclinical Test Summary:
The worse case plate from the Ankle Trauma System was tested against the predicate device using the standard ASTM F382-99 Standard Specification and Test Methods for Metallic Bone Plates. The OrthoPro plate was found to be substantially equivalent to the predicate device. The screws from the Ankle trauma system were tested against the predicate device using the standard ASTM F543-07 Standard Specification and Test Metallic Bone Screws. The screws from the Ankle Trauma System were found to be substantially equivalent to the predicate device.
Clinical Test Summary:
No clinical studies were performed.
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
§ 888.3030 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
Page 1 of 3
K122936
510(k) Summary
for The OrthoPro Ankle Trauma System In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for The OrthoPro Ankle Trauma system
FEB 2 8 2013
Date Prepared: September 21, 2012 Date Updated: January 28, 2013
-
- Submitter: OrthoPro LLC 3450 Highland Drive, Ste 302 Salt Lake City, UT 84106
Contact Person: Brock Johnson OrthoPro LLC 3450 Highland Drive, Ste 302 Salt Lake City, UT 84106 Telephone: 801-746-0208 ext 109
- Submitter: OrthoPro LLC 3450 Highland Drive, Ste 302 Salt Lake City, UT 84106
- Trade Name: Common Name:
Classification Name:
The OrthoPro Ankle Trauma System bone plate Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 21 CFR § 888.3030 HRS Class II
Predicate or legally market devices which are substantially equivalent: 3.
· LCP One-Third Tubular Plate - K011335 (Synthes)
· T-3.5mm LCP T-Plate - K000684 (Synthes)
· LCP Distal Tibia Plate - K013248 (Synthes)
4. Description of the device:
The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.
Materials:
Titanium alloy (Ti 6Al 4V ELI) per ASTM F136
- Indications for Use:
The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.
- દ. Comparison of the technological characteristics of the device to predicate and legally marketed devices: The OrthoPro Ankle Trauma system is substantially equivalent to the Synthes devices: One-Third Tubular Plate, T-3.5mm LCP T-Plate, LCP Distal Tibia Plate in terms of intended use, design, and
1
K122936
Page 2 of 3
materials used. The table below compares the features and characteristics of Ankle Trauma System to these predicate devices.
| Device
Name/Items | OrthoPro Ankle
Trauma System | Synthes LCP One-
Third Tubular Plate | Synthes T-3.5mm
LCP T-Plate | Synthes LCP Distal
Tibia Plate |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | OrthoPro LLC | Synthes (USA) | Synthes (USA) | Synthes (USA) |
| Device
Classification
Name | Single/Multiple
component metallic
fixation appliances and
accessories | Single/Multiple
component metallic
fixation appliances
and accessories | Single/Multiple
component metallic
fixation appliances and
accessories | Single/Multiple
component metallic
fixation appliances and
accessories |
| Product code | HRS | HRS | HRS | HRS |
| Regulation # | 888.3030 | 888.3030 | 888.3030 | 888.3030 |
| Classification | Class II | Class II | Class 11 | Class II |
| 510(k)
Number | K122936 | K011335 | K000684 | K013248 |
| Indications for
Use | The OrthoPro Ankle
Trauma system is
intended for fixation of
fractures, osteotomies,
and non-unions of the
clavicle, scapula,
olecranon, humerus,
radius, ulna, pelvis, distal
tibia, and fibula,
particularly in osteopenic
bone, The OrthoPro Ankle
Trauma system is
intended for fixation of
complex intra- and extra-
articular fractures and
osteotomies of the distal
tibia and other small
bones as a part of the
system. | Synthes Dynamic
Compression Locking
Plate System is
intended for fixation
of fractures,
osteotomies, and non-
unions of the clavicle,
scapula, olecranon,
humerus, radius, ulna,
pelvis, distal tibia, and
fibula, particularly in
osteopenic bone as
part of the Synthes
Small Fragment DCL
System | Fixation of fractures,
osteotomies, and non-
unions of the clavicle,
scapula, olecranon,
humerus, radius, ulna,
pelvis, distal tibia,
fibula particularly in
osteopenic bone. | The Synthes Locking
Compression Plate (LCP)
is intended for fixation of
fractures, osteotomies,
and non-unions of the
clavicle, scapula,
olecranon, humerus,
radius, ulna, pelvis, distal
tibia, and fibula,
particularly in osteopenic
bone, The Synthes LCP
Distal Tibia Plates are
intended for fixation of
complex intra- and extra-
articular fractures and
osteotomies of the distal
tibia and other small
bones as a part of the
system. |
| Material | Titanium | Titanium and
stainless steel | Titanium and
stainless steel | Titanium and
stainless steel |
| Configuration | Straight, Cloverleaf | Straight | Straight, T,
cloverleaf, T oblique
angle, curved | Cloverleaf |
| Profile | Scalloped | Straight | Straight, Scalloped | Straight |
| Screws | Locking and Non-
locking | Locking and Non-
locking | Locking and Non-
locking | Locking and Non-
locking |
| Sterility | Non-sterile | Sterile/Non-sterile | Sterile/Non-sterile | Sterile/Non-sterile |
7. Nonclinical Test Summary:
The worse case plate from the Ankle Trauma System was tested against the predicate device using the standard ASTM F382-99 Standard Specification and Test Methods for Metallic Bone Plates. The OrthoPro plate was found to be substantially equivalent to the predicate device. The screws from the Ankle trauma system were tested against the predicate device using the standard ASTM F543-07 Standard Specification and Test Metallic Bone Screws. The screws from the Ankle Trauma System were found to be substantially equivalent to the predicate device.
-
- Clinical Test Summary:
No clinical studies were performed.
- Clinical Test Summary:
2
.
:
.
.
.
:
·
.
.
9. Conclusions Nonclinical and Clinical:
:
The OrthoPro Ankle Trauma System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function; in most cases with respect to device function performed with superiority.
:
:
.
:
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
OrthoPro, LLC % Mr. Brock Johnson Vice President Operations 3450 Highland Drive Salt Lake City. Utah 84106
Re: K122936
Trade/Device Name: The OrthoPro Ankle Trauma System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 28, 2013 Received: February 8, 2013
Dear Mr. Johnson:
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
4
Page 2 - Mr. Brock Johnson
CFR Part 807); labeling (21 CFR Part 801); 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 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Erin जिलिंth
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(K) Number (if known): K122936
Device Name: The OrthoPro Ankle Trauma system
Indications for Use:
The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.
Prescription Use_X_ (Part 21 CFR 801.109) 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)
Elizabeth L. Frank -S
Division of Orthopedic Devices