(67 days)
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a hip system intended to replace a hip joint in patients with severe pain and disability, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is a hip implant intended for total hip replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a femoral short stem manufactured from titanium alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant designed to replace a hip joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implant (femoral short stem) made of titanium alloy with coatings, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Metha® Short Stem 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, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head 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
LWJ, MEH, LZO, KWY
Device Description
Metha® is a femoral short stem intended to replace the hip joint in total hip arthroplasty. The femoral stem is collarless, conical shaped and is intended for cementless, press-fit application. The femoral stem is manufactured from titanium alloy and is available in various sizes. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate(u-CaP®). It is designed for use with currently available Aescular Implant Systems femoral heads, acetabular components and Bipolar cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified . Metallic Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed . Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" . Modular Implant Components",
- "Draft Guidance for Femoral Stem Prostheses", .
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed . where applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042344, K060437, K060918, K030733
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Metha® Short Stem Hip System February 29, 2008
- COMPANY: Aesculap Implant Systems, Inc. 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: Metha®
- COMMON NAME: Metha® Short Stem Hip System
- 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 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented 888.3360, 888.3353, 888.3353, 888.3390 REGULATION NUMBER:
PRODUCT CODE: LWJ, MEH, LZO, KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, Inc. believes that the Metha® Short Stem Hip System is substantially equivalent to:
- Excia Total Hip System (K042344) .
- Excia Total Hip System with u-CaP® (K060437) .
- Excia Total Hip System 12/14 Trunnion with Ceramic Head (K060918) ●
- . MAYO® Conservative Hip Prosthesis (K030733)
1
DEVICE DESCRIPTION
Metha® is a femoral short stem intended to replace the hip joint in total hip arthroplasty. The femoral stem is collarless, conical shaped and is intended for cementless, press-fit application. The femoral stem is manufactured from titanium alloy and is available in various sizes. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate(u-CaP®). It is designed for use with currently available Aescular Implant Systems femoral heads, acetabular components and Bipolar cups.
INDICATIONS FOR USE
The Metha® Short Stem 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, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head 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 �
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Aesculap Implant Systems Metha® Short Stem Hip System are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified . Metallic Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed . Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" . Modular Implant Components",
- "Draft Guidance for Femoral Stem Prostheses", .
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed . where applicable.
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. c/o Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
Re: K080584 Trade/Device Name: Metha Short Stem Hip Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LZO, LWJ, KWY Dated: April 24, 2008 Received: April 25, 2008
MAY - 9 2008
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.
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.
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Page 2 - Ms. Kathy A. Racosky
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. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number: K080584
Device Name: Metha® Short Stem Hip System
Indications for Use:
The Metha® Short Stem 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, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head 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) Nille Dyn formen Division of General, Restorative, and Neurological Devices
510(k) Number K080584