(186 days)
Not Found
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat severe hip pain and disability due to various conditions, which aligns with the definition of a therapeutic device.
No
The device is a hip implant system, not a device used to diagnose medical conditions. Its purpose is to replace a hip joint.
No
The device description clearly outlines physical components made of titanium alloy and other materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace a hip joint" in patients with various hip conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "short stem design" hip system, including a femoral stem and an acetabular cup. These are implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Metha Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement .
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise and nonunion of previous fractures of the femur.
- patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- patients with acute femoral neck fractures .
Product codes (comma separated list FDA assigned to the subject device)
LWJ, MEH, LZO
Device Description
The Metha Hip Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femur
Indicated Patient Age Range
skeletally mature individuals
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 following testing was performed to support substantial equivalence: - Fatigue testing per ISO 7206-4 and ASTM F2068-03 . Testing demonstrated that the device is as safe, as effective, and performs as well as the 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.
K080584 & K071916, K030733 & K061461, K091423
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K 112 682
MAR 1 9 2012
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) 8.
Metha Hip System
February 29, 2012
COMPANY:
Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
CONTACT:
Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax)
Metha TRADE NAME:
Metha Hip System COMMON NAME:
CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis. Hip. Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
888.3360, 888.3353, 888.3353 REGULATION NUMBER:
LWJ, MEH, LZO PRODUCT CODE:
SUBSTANTIAL EQUIVALENCE
SUBSTANTIAL EGON ALLING
Aesculap Implant Systems, LLC believes that the Metha Hip Systems are substantially equivalent to:
- Metha Hip Systems (K080584 & K071916) .
- MAYO Conservative Hip Prosthesis (K030733 & K061461) .
- Profemur Hip System Modular Necks (K091423) .
1
DEVICE DESCRIPTION
The Metha Hip Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.
INDICATIONS FOR USE
The Metha Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement i .
- Skeletally mature individuals and disability due to rheumatoid arthritis, . patterits suitening from severe hip pain and city and disorders, avascular USteoathinis, "traumatio" antimal" poryious fractures of the femur.
- heciosis of the congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- patients with acute femoral neck fractures .
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
As is established in this submission, the Aesculap Implant Systems Melna Hip Systems As is established in this Submission, the Acceanap stem or a modular stem or a modular stem on the subjection are a short stem design with cither a cingle process cleared by FDA. The subject that are substantially equivalent to other productions the same technological device is shown to be substantially equivalism in design, intended use, onaterial composition, function and range of sizes.
PERFORMANCE DATA
As recommended by the FDA Guidance for Industry and FDA Staff - Non-clinical As recommended by the PDA Guldance for Industry and to recomments that the Metha Information for Femoral Stem Prosmose that perceive devices. The following testing was performed to support substantial equivalence: -
- Fatigue testing per ISO 7206-4 and ASTM F2068-03 .
Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure embracing or protecting something.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 9 2012
Aesculap Implant Systems, LLC. % Ms. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K112682
Trade/Device Name: Metha Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH, LWJ Dated: March 9, 2012 Received: March 12, 2012
Dear Ms. Rocosky:
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. Kathy A. Racosky
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 vours.
sincerely yours,
For
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
K112.682
510(k) Number:_
Device Name: Metha Hip System
Indications for Use:
The Metha Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement .
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise and nonunion of previous fractures of the femur.
- patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- patients with acute femoral neck fractures .
| Prescription Use | X | and/or Over-the-Counter Use | |
|---|---|---|---|
| ------------------ | --- | ----------------------------- | -- |
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices510(k) Number K112682
002