(75 days)
No
The device description focuses on the material, design, and mechanical features of an acetabular cup, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is an acetabular cup, which is an orthopedic implant used in hip replacement surgery, not a therapeutic device in the sense of providing active therapy or treatment. Its function is to replace a damaged anatomical part.
No
The device description indicates it is an acetabular cup, a prosthetic implant, and its intended use is for rehabilitating damaged hips, which is a treatment, not a diagnostic, function.
No
The device description clearly describes a physical implant made of UHMWPE with physical features like cement spacers, radiopaque wires, grooves, and scallops. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an acetabular cup for surgical implantation in the hip to rehabilitate damaged joints. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of UHMWPE, designed to be surgically placed in the hip joint. It describes its shape, materials, and features for surgical fixation.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
- Anatomical Site: The device is used directly within the hip joint, an anatomical site, not for testing samples outside the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID.JD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis. slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Product codes
JDI
Device Description
The ZCA Snap-In Cup is a single unit manufactured from ultra-high molecular weight polyethylene (UHMWPE). The interior of the cup is designed to allow snap fitting of a 32 mm head into the articular surface through matcrial interference around the inner diameter rim. The ZCA Snap-In Cup is designed with a neutral face and is provided in outer diameter sizes ranging from 49 to 61 mm in 2 mm increments to fit varying anatomical requirements. The ZCA Snap-In Cup is hemispherical in shape and has four press-fit PMMA cement spacers affixed to the outer diameter to centralize the cup and help maintain a uniform 3 mm cement mantle. Radiopaque stainless steel wires at the dome and equator are used to determine the location and orientation of the component radiographically. Grooves and scallops on the outer surface are used for optimal cement interdigitation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, acetabulum
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pre-amendment device, Pre-amendment device, K901240, K924115, K934765
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
APR 01 2003
page 1 of 2
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain
Manager, Regulatory Affairs
Telephone: (574) 372-4219
Fax: (574) 372-4605 |
| Date: | January 8, 2003 |
| Trade Name: | ZCA® All-Poly Acetabular Cup, Snap-In |
| Common Name: | All Polyethylene Acetabular Cup |
| Classification Names
and References: | Hip joint metal/polymer semi-constrained cemented
prosthesis (21 CFR § 888.3350) |
| Predicate Devices: | Trapezoidal-28® "Snap-On" Acetabular Cup
(preamendment device), manufactured by Zimmer,
Inc.
Müller Snap-On Acetabular Cup (postamendment
device), manufactured by Zimmer, Inc.
Zimmer Non-Metal Backed Acetabular Cup for
Cemented Fixation (formerly Astel), K901240,
cleared March 26, 1990
ULTIMA All-UHMWPE Cemented Acetabular
Cups, manufactured by Johnson & Johnson,
K924115, cleared November 24, 1992
Trilogy® Acetabular System Elevated Rim Liners,
manufactured by Zimmer, K934765, cleared April
29, 1994 |
| Device Description: | The ZCA Snap-In Cup is a single unit manufactured
from ultra-high molecular weight polyethylene
(UHMWPE). The interior of the cup is designed to
allow snap fitting of a 32 mm head into the |
1
030/53
page 2 of 2
articular surface through matcrial interference around the inner diameter rim. The ZCA Snap-In Cup is designed with a neutral face and is provided in outer diameter sizes ranging from 49 to 61 mm in 2 mm increments to fit varying anatomical requirements. The ZCA Snap-In Cup is hemispherical in shape and has four press-fit PMMA cement spacers affixed to the outer diameter to centralize the cup and help maintain a uniform 3 mm cement mantle. Radiopaque stainless steel wires at the dome and equator are used to determine the location and orientation of the component radiographically. Grooves and scallops on the outer surface are used for optimal cement interdigitation.
The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID.JD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis. slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The acetabular cups listed above are substantially equivalent to each other and the ZCA Snap-In Cup in that all are manufactured from the same or similar materials and are intended to replace the bearing surface of the acetabulum.
Intended Use:
Comparison to Predicate Devices:
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
APR 0 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K030153
Trade Name: ZCA All Poly Acetabular Cup, Snap-In Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: January 8, 2003 Received: January 16, 2003
Dear Ms. Cain:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Karen Cain
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 N. Milburn
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
KO30153
510(k) Number (if known):
Device Name:
ZCA® All-Poly Acetabular Cup, Snap-In
Indications for Use:
The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJ) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fuscd hip, fracture of the pelvis, and diastrophic variant.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (OD) E
(ODE)
Mark A. Milkevar
(Division Sign-Off)
Page 1 of 1
Division of G storative and Neurological
510(k) Number K030153
Prescription Use (Por 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)