(84 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a plating system used for fixation following osteotomies, which is an orthopedic implant, not a therapeutic device designed to cure or treat a disease through non-surgical means. It provides physical support and stability.
No
The device description and intended use indicate it is an implant system (plates, screws, spacer blocks) for surgical fixation following osteotomies, not a device used to provide diagnostic information about a patient's condition.
No
The device description explicitly states it consists of physical components like plates, screws, and spacer blocks made from Titanium/Titanium Alloy, indicating it is a hardware medical device.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a plating system intended for fixation following Proximal Tibial opening wedge osteotomies. This is a surgical procedure performed inside the body to stabilize bone.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with IVD devices.
This device is a surgical implant used for orthopedic procedures.
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
HRS
Device Description
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of tapered plates, 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.
Fatigue testing of the Position HTO Maxi Plate was performed to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) | ||
|---|---|---|---|
| High Tibial Osteotomy (HTO) Plating System | |||
| November 15, 2010 | NOV 2 4 •2010 | ||
| COMPANY: | Aesculap Implant Systems, LLC | ||
| 3773 Corporate Parkway | |||
| Center Valley, PA 18034 | |||
| Establishment Registration Number: 3005673311 | |||
| CONTACT: | Kathy A. Racosky | ||
| (610) 984-9291 (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) | |||
| REGULATION NUMBER: | 888.3030, 888.3040 |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the new HTO Maxi plate and screws are substantially equivalent to the existing plate and screws of the High Tibial Osteotomy (HTO) Plating System cleared under K080992.
DEVICE DESCRIPTION
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of tapered plates, 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
There have been no changes to the Indications for Use. It remains as follows:
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.
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PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the new HTO Maxi Plate and screws which are being added to the Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System.
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.
PERFORMANCE DATA
Fatigue testing of the Position HTO Maxi Plate was performed to support substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing 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 Room -WO66-G609 Silver Spring. MD 20993-0002
Aesculap Implant Systems, LLC % Ms. Kathy Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
NOV 2 4 2010
Re: K102505
Trade/Device Name: Aesculap Implant Systems High Tibial Osteotomy (HTTO) Plating 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 Dated: November 15, 2010 Received: November 17, 2010
Dear Ms. Racosky:
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
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 (OS) 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.htm1 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/ReportalProblem/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,
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
NOV 2 4 2010
510(k) Number: K102505
Device Name: Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating 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
and/or Over-the-Counter 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)
Spate for mxm
(Dwision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K.102505
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