(90 days)
Not Found
No
The document describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device replaces a damaged hip joint, which is a therapeutic intervention for noninflammatory degenerative joint disease (NIDJD) and its associated conditions.
No
Explanation: The device described is an acetabular cup system intended to replace a hip joint in surgery, rather than to diagnose a condition.
No
The device description clearly details physical components made of metal alloys (Tivanium Ti-6Al-4V Alloy and Trabecular Metal) intended for surgical implantation to replace a hip joint. This is a hardware medical device, not software-only.
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 for "primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease...". This describes a surgical implant used to replace a damaged joint.
- Device Description: The description details a "modular acetabular cup system intended to replace a hip joint". It describes the physical components of the implant (shell, liner, materials, screw holes).
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (inside the body) and does not perform any diagnostic testing on bodily specimens.
Therefore, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
This device is intended for either cemented or noncemented use.
Product codes
JDI, LPH
Device Description
The Zimmer Trabecular Metal Modular Acetabular System is a modular acetabular cup system intended to replace a hip joint and designed to achieve fixation to bone either with or without the use of bone cement. The system consists of a shell and liner. The shell substrate is made from Tivanium Ti-6Al-4V Alloy. The outer porous material, which is metallurgically bonded to the shell substrate, is made of Trabecular Metal. The Trabecular Metal material has an elliptical outer diameter and a hemispherical inner diameter to allow hemisphere to hemisphere bonding between the Trabecular Metal and the Tivanium substrate.
Three porous acetabular shell designs are available: one with screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80 mm in 2mm increments. The screw holes permit the use of Tivanium Allov screws to provide immediate fixation and security. Screws are available in 4.5 and 6.5mm diameters with varying lengths. The shell incorporates a threaded polar hole to attach the cup positioner.
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)
Non-Clinical Performance and Conclusions:
The Trabecular Metal/Tivanium alloy interface was tested per applicable FDA Guidance Documents and ASTM Standards and the results demonstrated that the interface will maintain its integrity under physiological loads.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "zimmer" in bold, black font. To the left of the word is a circle with a bold, black "Z" inside. The "Z" is stylized with a break in the middle of the letter.
5 2002 SEP
Summary of Safety and Effectiveness
K021891
page 1 of 2
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred McClure
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4294
Fax: (574) 372-4605 |
| Date: | June 6, 2002 |
| Trade Name: | Zimmer Trabecular Metal Modular Acetabular
System |
| Common Name: | Acetabular component for total Hip prosthesis |
| Classification Name
and Reference: | Hip joint metal/polymer semi-constrained cemented
prosthesis; 21 CFR § 888.3350
Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis;
21 CFR § 888.3358 |
| Predicate Device: | Trilogy ® Acetabular System, manufactured by
Zimmer, Inc., (K934765), cleared April 29, 1994;
and Implex Hedrocel Modular Elliptical Acetabular
Cup, manufactured by Implex Corp., (K001039),
cleared June 15, 2000. |
| Device Description: | The Zimmer Trabecular Metal Modular Acetabular
System is a modular acetabular cup system intended
to replace a hip joint and designed to achieve
fixation to bone either with or without the use of
bone cement. The system consists of a shell and
liner. The shell substrate is made from Tivanium ®
Ti-6Al-4V Alloy. The outer porous material, which
is metallurgically bonded to the shell substrate, is
made of Trabecular Metal. The Trabecular Metal
material has an elliptical outer diameter and a
hemispherical inner diameter to allow hemisphere
to hemisphere bonding between the Trabecular
Metal and the Tivanium substrate. |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, and the circle is thin and black. The word "zimmer" is also black and in a sans-serif font.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical
and/or Clinical):
Kcd1891
page 2 of 2
Three porous acetabular shell designs are available: one with screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80 mm in 2mm increments. The screw holes permit the use of Tivanium Allov screws to provide immediate fixation and security. Screws are available in 4.5 and 6.5mm diameters with varying lengths. The shell incorporates a threaded polar hole to attach the cup positioner.
This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. This device is intended for either cemented or
noncemented use.
The Zimmer Trabecular Metal Modular Acetabular System incorporates the same materials, has the same intended use, and similar technological and geometrical features as the legally marketed predicate devices.
Non-Clinical Performance and Conclusions:
The Trabecular Metal/Tivanium alloy interface was tested per applicable FDA Guidance Documents and ASTM Standards and the results demonstrated that the interface will maintain its integrity under physiological loads.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
0016
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 SEP
Mr. Fred McClure Senior Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw. IN 46581-0708
Re: K021891
Trade Name: Zimmer Trabecular Metal Modualr Acetabular System Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II
Product Code: JDI and LPH Dated: June 6, 2002 Received: June 7, 2002
Dear Mr. McClure:
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 – Mr. Fred McClure
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.
Stept Rlwdw
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
Page 1 of 1
KO21891 510(k) Number (if known):
Device Name:
Zimmer® Trabecular Metal Modular Acetabular System
Indications for Use:
This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
This device is intended for either cemented or noncemented use.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K 021891 |
|---|---|
| --------------- | ---------- |
| Prescription Use X (Per 21 CFR 801.109) | OR Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|
| ----------------------------------------- | -------------------------------------------------- |