(210 days)
Not Found
No
The 510(k) summary describes a standard hip replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "Hip System" intended to "replace a hip joint" for patients suffering from severe hip pain and disability due to various medical conditions, indicating a direct therapeutic purpose.
No
The device is a prosthesis intended to replace a hip joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of metal and polymer (femoral stem, femoral head, acetabular cup), indicating it is a hardware medical device.
Based on the provided information, 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 suffering from various conditions affecting the hip. This is a surgical implant used in vivo (within the body).
- Device Description: The device is a hip prosthesis consisting of a femoral stem, femoral head, and acetabular cup. These are physical implants.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The BiCONTACT Hip System (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 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)
LPH
Device Description
The BICONTACT Hip Stem and Femoral Head are available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore). 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, femoral head
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 Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Draft Guidance for Femoral Stem Prostheses" 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.
K022077, K023102, K030733, K022902, K041109
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
AUG 2 5 2004
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS C. [in Accordance with SMDA of 1990]
BiCONTACT Hip System
K 04019/
January 26, 2004
-
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 2916714 -
CONTACT: Joyce Kilroy 800/258-1946 x 5074 (phone) 610/791-6882 (fax)
BiCONTACT TRADE NAME:
COMMON NAME: BiCONTACT Hip System
DEVICE CLASS: Class II
PRODUCT CODE: LPH
- CLASSIFICATION: 888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
REVIEW PANEL: Orthopedics
INDICATIONS FOR USE
The BiCONTACT Hip System (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 epiphysis
- Patients suffering from disability due to previous fusion ◆
- Patients with acute femoral neck fractures ◆
DEVICE DESCRIPTION
The BICONTACT Hip Stem and Femoral Head are available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.
1
Page 2 of 2
040/91
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 Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Draft Guidance for Femoral Stem Prostheses" was completed where applicable. .
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the new BiCONTACT Hip Stem and Femoral Head is substantially equivalent in design to:
-
. 36mm V40 Femoral Head Components (K022077)
-
Accolade TMZF Plus HA 127° Size Hip System (K023102) .
-
. MAYO Conservative Hip Prosthesis (K030733)
-
Smith & Nephew Hip System (K022902) .
-
Zimmer Anatomic (K041109) 9
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K040191
Trade/Device Name: BiContact Hip Stem and Femoral Head Regulation Number: 21 CFR 888.3358 Regulation Name: Prosthesis, Hip, semi-constrained, metal/polymer, porous uncemented Regulatory Class: II Product Code: LPH Dated: August 12, 2004 Received: August 13, 2004
Dear Ms. Kilroy:
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. Joyce Kilroy
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millan
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
4
INDICATIONS FOR USE STATEMENT B.
Page 1 of 1
K040191 510(k) Number:
BiCONTACT Hip System Device Name;
Indication for Use:
The BiCONTACT Hip System (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 epiphysis
- Patients suffering from disability due to previous fusion ●
- Patients with acute femoral neck fractures .
Mark A. Milliken
Restorative, and Neurological
K04019
mber
Prescription Use X
(per 21 CFR 801.109)
or Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)