(267 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of a bone plate system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed for treating fractures and osteotomies of the proximal humerus, which are medical conditions, thereby providing a therapeutic benefit.
No
The provided text describes a medical device designed for treating fractures and pseudoarthroses of the proximal humerus, not for diagnosing medical conditions. It is a surgical implant system.
No
The device description explicitly states it is composed of physical components made from stainless steel, including plates and screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Ascension ATLAS® Humeral Fracture Plate system is described as a system of plates and screws made from stainless steel, designed to be implanted in the proximal humerus to treat fractures and other bone issues.
- Intended Use: The intended use clearly states it's for treating fractures, dislocations, osteotomies, and non-unions of the proximal humerus. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used to stabilize bone, which falls under the category of orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
- Pseudoarthroses in the proximal humerus
- Osteotomies in the proximal humerus
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Ascension® ATLAS® Humeral Plate System will be composed of left and right humeral reconstruction plate implants in four-hole (HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will also feature 3.5mm locking, non-locking and lag screws and 2.7mm locking and non-locking screws.
The ATLAS® Humeral Fracture Plate will be a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws will be made from stainless steel (SS 316L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
The ATLAS Humeral Fracture Plate meets the test specifications for ASTM F382-99, part A1.
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
510(k) Summary
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road
Austin, TX 78754-3832 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Susan Walton |
| | swalton@ascensionortho.com
Phone: (512) 836-5001 x1591
Toll Free FAX (888) 508-8081
Alternate FAX (512) 836-6933 |
| TRADE NAME: | Ascension® ATLAS® Humeral Fracture Plate System |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | 21 CFR 888.3030 - Single/Multiple component metallic bone
fixation appliances and accessories |
| PRODUCT CODE: | HRS |
| PANEL: | Orthopedic |
| PREDICATE DEVICE: | K011815 - Synthes LCP Proximal Humerus Plate |
| DEVICE
DESCRIPTION: | The Ascension® ATLAS® Humeral Plate System will be composed
of left and right humeral reconstruction plate implants in four-hole
(HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-
007LS, HFP-0930-007RS) lengths or sizes. The system will also
feature 3.5mm locking, non-locking and lag screws and 2.7mm
locking and non-locking screws. |
| | The ATLAS® Humeral Fracture Plate will be a single component
made from stainless steel (SS 316L). The non-locking, locking and
lag screws will be made from stainless steel (SS 316L). |
| INTENDED USE: | The Ascension ATLAS® Humeral Fracture Plate system is designed fo
fractures and fracture dislocations, osteotomies and non-unions of the
proximal humerus. Indications include: |
| | Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bonePseudoarthroses in the proximal humerusOsteotomies in the proximal humerus |
| SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS: | The technological characteristics for the Ascension ATLAS
Humeral Fracture Plate System were compared to the predicate
device, the Synthes LCP Proximal Humerus Plate (K011815). The
technological characteristics were defined to be plate length, number
of holes and location of the holes as well as screw sized. These
characteristics were determined to be the same or similar to the
predicate device. |
|( || 0700 ( || 2)
--
1
K 110700(zlz)
NONCLINICAL TESTING
BASIS OF SUBSTANTIAL EQUIVALENCE:
The ATLAS Humeral Fracture Plate meets the test specifications for ASTM F382-99, part A1.
Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate device based on similarities in design, materials and indications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
l'ood and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopedics, Inc. % Ms. Susan Walton 8700 Cameron Road Austin, Texas 78754
DEC - 6 2011
Rc: K110700
Trade/Device Name: Ascension® ATLAS® Humeral Fracture Plate 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: October 20, 2011 Received: October 21, 2011
Dear Ms. Walton:
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 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
3
Page 2 - Ms. Susan Walton
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/CDRHQffices/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/McdicalDevices/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/Resourcesfor You/Industry/default.htm.
Sincerely your
Por D.m
Dep con Dip
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KII0700 (11)
Indications for Use Statement
510(K) Number:
Ascension® ATLAS® Humeral Fracture Plate System Device Name:
Indications for Use:
The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications Include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including A fractures involving osteopenic bone
- A Pseudoarthroses in the proximal humerus
- A Osteotomies in the proximal humerus
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart B) OR
Over-The-Counter Use (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Ores for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number