Who is the manufacturer of ANKLE TRAUMA SYSTEM?

Orthopro, LLC filed the 510(k) submission for ANKLE TRAUMA SYSTEM (K122936).

What is the FDA product code for ANKLE TRAUMA SYSTEM?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ANKLE TRAUMA SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ANKLE TRAUMA SYSTEM?

LCP One-Third Tubular Plate (K011335); T-3.5mm LCP T-Plate (K000684); LCP Distal Tibia Plate (K013248).

Who can help prepare an FDA 510(k) submission like ANKLE TRAUMA SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANKLE TRAUMA SYSTEM

K122936 · Orthopro, LLC · HRS · Feb 28, 2013 · Orthopedic

Device Facts

Record ID	K122936
Device Name	ANKLE TRAUMA SYSTEM
Applicant	Orthopro, LLC
Product Code	HRS · Orthopedic
Decision Date	Feb 28, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

System consists of titanium alloy plates (straight, cloverleaf configurations) and bone screws for internal fixation of bone fractures, osteotomies, and non-unions. Manual surgical instruments provided for implantation. Used by surgeons in clinical settings (OR) to stabilize bone fragments. Provides mechanical support to facilitate bone healing. Benefits include stabilization of complex fractures, particularly in osteopenic bone.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by nonclinical bench testing.

Technological Characteristics

Titanium alloy (Ti 6Al 4V ELI) per ASTM F136. Mechanical fixation via plates and screws. Plates feature straight and cloverleaf configurations with scalloped profiles. Non-sterile. Testing performed per ASTM F382-99 (plates) and ASTM F543-07 (screws).

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including complex intra- and extra-articular fractures, particularly in osteopenic bone.

Regulatory Classification

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.

Predicate Devices

LCP One-Third Tubular Plate (K011335)
T-3.5mm LCP T-Plate (K000684)
LCP Distal Tibia Plate (K013248)

Related Devices

K101240 — CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 · DePuy Orthopaedics, Inc. · Jul 23, 2010
K181843 — MLP Special Locking Bone Plate System · Maxxion Medical, LLC / Baumer SA · Mar 4, 2019
K190391 — TDM Plate and Screw Systems · Tdm Co., Ltd. · Nov 15, 2019
K190430 — OsteoCentric Bone Plate and Screw System · Osteocentric Trauma · Mar 22, 2019
K232115 — TDM Large Bone Plate and Screw System · Tdm Co., Ltd. · Apr 5, 2024

Submission Summary (Full Text)

{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 - 1. 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 2. 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 5. 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. - 8. Clinical Test Summary: No clinical studies were performed. {2}------------------------------------------------ K122936 . : . . . : · . - . #### 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