(80 days)
Not Found
No
The 510(k) summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical properties and equivalence to predicate devices.
Yes
The device is described as "plates and screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries," which directly implies its use in treating medical conditions.
No
The device is a plating system used for stabilization and fixation of fractures and reconstructive surgeries, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of plates and screws manufactured from Titanium alloy and CoCr, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Description and Intended Use: The DePuy ALPS Small Bone Locked Plating System is described as a system of plates and screws used for the stabilization and fixation of bones within the body (in vivo). Its intended use is for surgical procedures to treat fractures, fusions, reconstructions, etc.
The device is a surgical implant used directly on the patient's bones, not for testing biological samples.
N/A
Intended Use / Indications for Use
The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DePuy ALPS Small Bone Locked Plating System consists of a series of plates and screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis
Indicated Patient Age Range
adult and pediatric patients (adolescents [>12 - 21 years of age])
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)
Testing included construct static bending and galvanic corrosion testing, in addition to a comparison of indications for use, materials, device geometry and design forming a basis for a determination of substantial equivalence to legally marketed predicate devices.
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
可 240
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:
Section 5 — 510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 2 3 2010 |
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs |
| Date Prepared: | April 29, 2010 |
| Proprietary Name: | DePuy ALPS Small Bone Locked Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and
accessories (21 CFR § 888.3030) |
| Predicate Devices: | The DePuy ALPS Small Bone Locked Plating System is substantially
equivalent to currently marketed devices including DePuy's LCL &
Fusion Plating System (K091294) and Mini Fragment Plating System
(K061748). |
| Device Description: | The DePuy ALPS Small Bone Locked Plating System consists of a
series of plates and screws manufactured from Titanium alloy and
CoCr used in bone fixation and the management of fractures and
reconstructive surgeries. |
| Indications for Use: | The DePuy ALPS Small Bone Locked Plating System is intended for
use in stabilization and fixation of fractures, revision procedures,
fusions, reconstructions (osteotomy) and non-unions of the bones of
the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle,
scapula and pelvis, particularly in osteopenic bone. The system can
be used in both adult and pediatric patients (adolescents [>12 - 21
years of age]), where the implant would not cross open epiphyseal
plates in skeletally immature patients. |
| Technological
Characteristics: | The technological characteristics of the DePuy ALPS Small Bone
Locked Plating System are similar to the predicate devices including
design and material. |
| Summary of
Substantial
Equivalence: | The DePuy ALPS Small Bone Locked Plating System is substantially
equivalent to currently marketed devices as demonstrated with pre-
clinical data. Testing included construct static bending and galvanic
corrosion testing, in addition to a comparison of indications for use,
materials, device geometry and design forming a basis for a
determination of substantial equivalence to legally marketed
predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines representing the body and a base that looks like intertwined snakes or roots.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 3 2010
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K101240
Trade/Device Name: DePuy ALPS Small Bone Locked Plating System Regulation Number: 21 CFP. 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 29, 2010 Received: May 4, 2010
Dear Ms. Otaño:
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
2
Page 2 - Ms. Suzana Otaño
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number:
DePuy ALPS Small Bone Locked Device Name: Plating System
Indications For Use:
The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quta for nxm
Division Sign off
(Division Sign Off) Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K101240
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