(150 days)
Not Found
No
The description focuses on the mechanical components of a plating system and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a surgical implant designed for fixation following osteotomies, which is a structural or mechanical support, not a device that provides therapy for a disease or condition.
No
Explanation: This device is a plating system intended for fixation after osteotomies, which is a therapeutic rather than diagnostic function. It provides structural support and does not gather or interpret data to diagnose a condition.
No
The device description explicitly states it consists of a plate, screws, and spacer blocks, all of which are physical 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 "fixation following Proximal Tibial opening wedge osteotomies." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Plating System" consisting of plates, screws, and spacer blocks. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used to stabilize bone.
N/A
Intended Use / Indications for Use
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Tibial
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)
Biomechanical testing of the subject device was found to be similar in performance to previously cleared high tibial osteotomy systems with similar indications.
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
KOS0992
SEP - 4 2008
Page 1 of 1
510(k) SUMMARY (as required by 21 CFR 807.92)
High Tibial Osteotomy (HTO) Plating System April 7, 2008
| COMPANY: | Aesculap Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
(610) 984-9274 (phone)
610-791-6882 (fax) |
| TRADE NAME: | HTO Plating System |
| COMMON NAME: | High Tibial Osteotomy (HTO) Plating System |
| CLASSIFICATION NAME: | Plate, Fixation, Bone (HRS)
Screw, Fixation, Bone (HWC) |
SUBSTANTIAL EQUIVALENCE
REGULATION NUMBER: 888.3030 / 888.3040
Aesculap Implant Systems, Inc., believes that the HTO Plating System is substantially equivalent to the Arthrex Puddu Osteotomy System (K973812).
DEVICE DESCRIPTION
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.
INDICATIONS FOR USE
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Implant Systems HTO Plating System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared high tibial osteotomy systems with similar indications.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
SEP - 4 2008
Re: K080992
Trade/Device Name: High Tibial Osteotomy (HTO) Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 5, 2008 Received: August 5, 2008
Dear Ms. Boyle:
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating Device Name:
System
Indications for Use:
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
Barbara Brelund for npm
(Division of General, Restorative, and Neurological Devices
510(k) Number
K083094