(30 days)
Not Found
No
The document describes a mechanical hip implant and does not mention any AI or ML components or functionalities.
Yes
The device is a hip implant, which is used to replace a hip joint to treat severe hip pain and disability due to various conditions. Devices designed to treat or alleviate disease are classified as therapeutic devices.
No
The device is a prosthesis intended to replace a hip joint, which is a therapeutic function, not a diagnostic one. It is used to treat existing conditions rather than to identify or determine the nature of a disease.
No
The device description clearly outlines physical components made of Ti, CoCrMo, and UHMWPE, indicating it is a hardware-based medical device.
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 "prosthesis, hip, semi-constrained, metal/polymer, porous uncemented" intended to "replace a hip joint." This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details the materials and components of a hip implant (femoral stem, femoral head, acetabular cup). These are physical components 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 treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the BiContact Hip System with u-CaP® is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.
The device is intended for:
- 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 . eptiphysis
- . 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)
87MEH, MEH
Device Description
The BiContact Hip System with u-CaP® is available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore®) and a layer of Calcium Phosphate. This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.
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
Not Found
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): 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.
K040191, K023102, K020963, K953111
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
DEC - 8 2004
Image /page/0/Picture/3 description: The image shows a handwritten string of characters, "K043079". The characters are written in a bold, somewhat messy style, with thick strokes. The numbers are easily readable, and the letter K is distinct.
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
BICONTACT HIP SYSTEM with u-CAP®
November 5, 2004
- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
- Kathy A. Racosky, Regulatory Affairs Associate CONTACT: 800-258-1946 (phone) 610-791-6882 (fax) kathy.racosky @ aesculap.com (email)
- TRADE NAME: BiContact
- BiContact Hip System with u-CaP® COMMON NAME:
- DEVICE CLASS: Class II
- PRODUCT CODE: 87MEH
- Orthopedic REVIEW PANEL:
INTENDED USE
The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.
The device is intended for:
- 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 . eptiphysis
- . Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures .
DEVICE DESCRIPTION
The BiContact Hip System with u-CaP® is available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore®) and a layer of Calcium Phosphate. This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.
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1
043079
Page 2 of 2
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.
SUBSTANTIAL EQUIVALENCE
The Aesculap BiContact Hip System with u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111).
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2004
Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap Inc 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K043079
Trade/Device Name: BiContact Hip System with μ-Cap Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: November 5, 2004 Received: November 9, 2004
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 10 mover ce 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) I mis letter will and in yours ough anding of substantial equivalence of your device to a legally prematicated predicated on "The 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 If you desire spocific acrievier - at (240) 276-0210. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Whisofanding by reference to premains on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milhem
Celia M. Witten, Ph.D., M.D. 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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: BiContact Hip System with u-CaP®
Indication for Use:
The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.
The device is intended for:
- . 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 ● eptiphysis
- Patients suffering from disability due to previous fusion .
- Patients with acute femoral neck fractures .
Mark A. Mullens
(Division Sign-Off)
Prescription Use __
(per 21 CFR 801.109)
or Over-the Dissio ral, Restorative. and Neurological Devices
510(k) Number K043079
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)