(41 days)
Not Found
No
The 510(k) summary describes a traditional orthopedic implant (hip replacement system) and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is intended to replace a hip joint for patients suffering from various conditions, aiming to alleviate pain and disability, which falls under the definition of a therapeutic device.
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 the device is a physical implant made of CoCrMo, which is a hardware component.
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 Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
Therefore, based on the provided information, the Metha® Short Stem Hip System is a surgical implant, not an In Vitro Diagnostic device.
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 dvsplasia, 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, KWY
Device Description
The Metha® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.
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 Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. 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 Document for Testing Acetabular Cup Prostheses", .
- "Points to Consider for Femoral Stem Prostheses". .
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices" was completed where applicable.
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Metha@ Short Stem Hip System XL Femoral Head
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
SEP 0 9 2008
Metha® Short Stem Hip Sytem (Metha® XL Femoral Head)
July 29, 2008
- Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
- CONTACT: Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy.racosky@aesculap.com (email)
- Metha® Short Stem Hip System XL Femoral Head TRADE NAME:
- Femoral Head COMMON NAME:
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented
- 888.3360, 888.3353, 888.3390 REGULATION NUMBER:
- PRODUCT CODE: LWJ, MEH, KWY
SUBSTANTIAL EQUIVALENCE
Aesculab Implant Systems. Inc. believes that the XL Femoral Head is a line extension of Aesculap Implant Systems, Inc. Metha@ Short Stem Hip System that was cleared (KO80584). It is also substantially equivalent to the BiContact Hip System and Femoral Head (K040191).
DEVICE DESCRIPTION
The Metha® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.
ייא | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
JUL 3 0 2003
駅から徒歩2分
003
1
SPECIAL 510(k) Premarket Notification
Methard Short Stern Hip System XL Fernoral Head
Page 2 of 2
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 dvsplasia, 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 new XL femoral CoCrMo heads of the Metha® Short Stem Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Asseculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. 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 Document for Testing Acetabular Cup Prostheses", .
- "Points to Consider for Femoral Stem Prostheses". .
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball . Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in 방 Orthopedic Devices" was completed where applicable.
MANUFACTURING FACILITY
Aesculap AG Am Aesculad-Platz Tuttlingen Germany
004
2
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 outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.
SEP 0 9 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acsculap Implant Systems, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K082146 Trade/Device Name: Metha® Short Stem Hip System XL Femoral Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ, MEH, KWY Dated: August 27, 2008 Received: August 28, 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 (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 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 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 Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K082/46
SPECIAL 510(k) Premarket Notification
Metha@ Short Stern Hip System XL Femoral Mead
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
SEP 0 9 2008
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Metha® Short Stem Hip System XL Femoral Head
Indications for Use:
The Metha® Short Stem Hip System (uncemented, press-filt fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement ﻮ
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the temoral 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 #
X and/or Over-the-Counter Use _ Prescription 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)
Concurrence of CDRH, O
Mark A. Millerson
(Division Sign-C Division of General, Restorative, and Neurological
002
Neurological Devices
510(k) Number K082146