(327 days)
No
The 510(k) summary describes a mechanical hip implant system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to replace a hip joint for patients suffering from various conditions causing hip pain and disability, which aligns with the definition of a therapeutic device as it treats or alleviates a medical condition.
No
The device is a hip implant system intended for total hip replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a modular system consisting of a stem and neck, manufactured from titanium alloy and CoCr29MO, with plasma sprayed and Calcium Phosphate coatings. This indicates a physical implant, not software.
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.
- Device Description and Intended Use: The provided information clearly describes a surgical implant intended to replace a hip joint. It is a physical device that is surgically placed within the body.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
The information provided aligns with a typical submission for a Class II or Class III medical device (specifically, an orthopedic implant) that is surgically implanted.
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, 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, KWY
Device Description
The Metha® Hip System is a modular system which consists of two components: the stem and the neck. Each component is available in various sizes. The conical shaped stem is manufactured from titanium alloy. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®). This stem is designed for cementless use only.
The modular cone adapter ootion allows the user to choose a combination of stem, neck, and nead component to appropriately fit the individual palient. The modular cone adapter is manufactured from CoCr29MO.
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, K012091, K030733, K043123
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
| K071916 | ||||
|---|---|---|---|---|
| 510(k) | SUMMARY (as | required by 21 | CFR | 807.92) |
JUN - 2 2008
Metha® Hip System
July 10, 2007
| COMPANY: | Aesculap Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673313 |
| ---------- | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- CONTACT: Kathy A. Racosky 610-984-5092 (phone) 610-791-6882 (fax)
TRADE NAME: Metha@
B.
COMMON NAME: Metha® Hip System
- CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented REGULATION NUMBER: 888.3360, 888.3353, 888.3390
PRODUCT CODE: LWJ, MEH, KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, Inc. believes that the Metha® Hip System is substantially equivalent to:
- 兼 Excia Total Hip System (K042344)
- Excia Total Hip System with u-CaP® (K060437) 参
- Pro-Femur (K012091) 事
- MAYO® Conservative Hip Prosthesis (K030733) 후
- Apex Modular HA Hip Stem (K043123) ◆
DEVICE DESCRIPTION
The Metha® Hip System is a modular system which consists of two components: the stem and the neck. Each component is available in various sizes. The conical shaped stem is manufactured from titanium alloy. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®). This stem is designed for cementless use only.
The modular cone adapter ootion allows the user to choose a combination of stem, neck, and nead component to appropriately fit the individual palient. The modular cone adapter is manufactured from CoCr29MO.
1
INDICATIONS FOR USE
The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip loint.
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 meumatoid ۽ 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 事
- patients with acute femoral neck fractures 事
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The components of the Aesculap Implant Systems Metha® 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 事 Metallic Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed 事 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", 事
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed 業 where applicable.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K071916 Trade/Device Name: Metha® Hip System 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, LWJ, KWY Dated: April 30, 2008 Received: May 1, 2008
JUN - 2 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.
3
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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A
610(k) Number: K0719119116
Device Name: Metha® Hip System
Indications for Use:
(per 21 CFR 801.109)
The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature inclividuals undergoing primary surgery for total hip 学 replacement
- patients suffering from severe hip pain and disability due to rhoumatoid 章 arthritis, osteoarthritis, traumatic anthritis, 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 兼 capital femoral epiphysis
- patients suffering from disability due to previous fusion 着
Prescription Use
- patients with acute femoral neck fractures 德
Neil Rpod for mkm
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR office of Device Evaluation (ODE)
(Division Sign-Office
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K071916 |
|---|---|
| --------------- | --------- |