(77 days)
No
The 510(k) summary describes a hip replacement system consisting of physical components (femoral heads, stems, adapters). There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies focus on mechanical testing of the physical device.
Yes
The device is described as the "Excia Hip System" and the "Metha® Hip System," both intended to "replace a hip joint" for patients suffering from severe pain and disability due to various conditions, indicating its use for therapeutic purposes.
No
The device description and intended use clearly state that the Excia Hip System is an orthopedic implant intended to replace a hip joint, not to diagnose a condition.
No
The device description clearly outlines physical components like femoral heads, stems, and adapters made of materials like CoCrMo, Ti, and ceramic. This indicates a hardware-based medical device, not software-only.
No, 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 involving the implantation of a medical device, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Hip System" consisting of femoral stems, ceramic heads, and adapters. These are physical implants designed to replace anatomical structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, based on the provided information, the Excia Hip System and Metha Hip System are orthopedic implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid arthritis, 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 previous fusion
- Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.
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, 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
LZO, LWJ, MEH, KWY
Device Description
The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty.
Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, 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)
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 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)
K042344, K060918, K062684, K071916, K080584, K082146, K082991, K071535
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
h090299 (pg 1/2)
SPECIAL 510(k) Premarket Notification
Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
APR 24 2009
BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads
and Metha® XL Heads
February 5, 2009
| 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)
kathy.racosky@aesculap.com (email) |
| TRADE NAME: | BIOLOX® OPTION Ceramic Femoral Head System and
Metha® XL Heads |
| COMMON NAME: | Total Hip System |
| | CLASSIFICATION NAME: Hip joint Metal/Ceramic/Polymer Semi-Constrained Cemented or
Non-Porous Uncemented Prosthesis
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: | 888.3353, 888.3360, 888.3353, 888.3390 |
PRODUCT CODE: LZO. LWJ, MEH, KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, Inc. believes that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aescular Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). It is also substantially equivalent to the Zimmer BIOLOX® OPTION Ceramic Femoral Head System (K071535).
DEVICE DESCRIPTION
The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty.
Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).
1
SPECIAL 510(k) Premarket Notification
Page 2 of 2
BIOLOX® OPTION Ceramic Fernoral Head Syste and Metha® XL Heads
INDICATIONS FOR USE
The Excia Hip System is intended to replace a hip joint.
- The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral hims, tradination of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
- Patients suffering from disability due previous fusion
- Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and re numeratured from Ti with Plasmapore with or without u-CaP®.
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, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of provious 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 Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads are offered in similar 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 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner.
APR 2 4 2009
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: K090299 Trade/Device Name: Novation Biolox® Option Ceramic Femoral Head and Metha XL Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LWJ, MEH, KWY Dated: March 26, 2009 Received: March 27, 2009
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 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 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
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 of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Oshm Def D.K
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SPECIAL 510(k) Premarket Notification
BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number: K090299 (pg 1/1)
BIOLOX® OPTION Ceramic Femoral Head System Device Name: For use with the Aesculap Implant Systems Excia and Metha® Hip Systems
Indications for Use:
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
Patients suffering from severe hip and disability due to rheumatoid anhritis, 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 previous fusion .
- Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.
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 disablity due to meumatoid arthritis, traumatic arthrits, 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 × and/or Over-the-Counter Use (per 21 CFR 801.109)
U
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Chamage Brill
Division of General, Restorative. and Neurological Devices
002