(87 days)
These devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
The Zimmer Unicompartmental Knee System (Zimmer Uni) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.
This document is a 510(k) summary for the Zimmer Unicompartmental Knee System and does not contain information about the acceptance criteria or a study proving the device meets said criteria as typically found in reports for AI/software devices. Instead, it describes a traditional medical device (a knee prosthesis) and its clearance based on substantial equivalence to predicate devices, rather than performance metrics from a specific study against acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text because they pertain to performance testing and validation typically associated with AI or diagnostic devices, which is not the subject of this 510(k) summary.
Here's what can be extracted based on traditional medical device clearance:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For traditional medical devices like this knee prosthesis cleared via 510(k), the primary "acceptance criterion" for market clearance is substantial equivalence to a legally marketed predicate device. This means demonstrating that the new device is as safe and effective as the predicate. The document states this explicitly.
- Reported Device Performance:
- Non-Clinical Performance: "Performance testing completed as part of the design assurance procedure for the Zimmer Unicompartmental Knee System and FMEA demonstrated that this device is safe and effective and substantially equivalent to the predicate devices." No specific quantitative metrics or acceptance criteria for this non-clinical testing are provided in this summary.
- Clinical Performance: "Clinical data and conclusions were not needed for this device."
| Acceptance Criteria (for 510(k) Clearance) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence in indications, design (non-constrained, unicompartmental knee prostheses), materials, and mechanical safety to the Miller/Galante Precoat Unicompartmental Knee System. |
| Safety and Effectiveness based on Non-Clinical Testing | Performance testing (design assurance, FMEA) demonstrated the device is safe and effective. Specific metrics not provided. |
| Clinical Data | Not needed for this device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable and not provided. The clearance is based on substantial equivalence and non-clinical testing, not a clinical study with a "test set" in the context of AI/diagnostic device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. There was no clinical ground truth established for a test set in the context of this 510(k) clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable and not provided. This is a physical medical implant, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's clearance is its demonstrated substantial equivalence to already approved predicate devices through non-clinical testing and comparison of design, materials, and intended use. There is no specific clinical "ground truth" (like pathology or outcomes data from a prospective study) described as being used for this 510(k) clearance.
8. The sample size for the training set
- This information is not applicable and not provided. There is no "training set" in the context of this device's clearance.
9. How the ground truth for the training set was established
- This information is not applicable and not provided.
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| JAN 1 6 2004 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Stephen McKelveyManager, Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605 |
| Date: | October 17, 2003 |
| Trade Name: | Zimmer Unicompartmental Knee System |
| Common Name: | Unicompartmental Knee |
| Classification Nameand Reference: | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, 21 CFR §888.3520 |
| Predicate Device: | The predicate devices for the ZimmerUnicompartmental Knee System are theMiller/Galante Precoat Unicompartmental KneeSystem, K880155 (cleared 8/3/88) and theMiller/Galante Precoat UnicompartmentalKnee System (8 mm Articular Surface) LineExtension, K010685 (cleared 4/2/01). |
| Device Description: | The Zimmer Unicompartmental Knee System(Zimmer Uni) is a prosthesis that replaces only onecompartment of the knee condyles. It isunconstrained in the anteroposterior andmediolateral directions and also allowsunconstrained internal/external rotation between thefemoral and tibial components. This movement islimited only by the ligaments and other soft tissuessurrounding the device. |
| Intended Use: | These devices are indicated for patients with: |
| - Painful and/or disabling knee joints due toosteoarthritis or traumatic arthritis. | |
| - Previous tibial condyle or plateau fractureswith loss of anatomy or function.- Varus or valgus deformities.- Revision of previous arthroplasty procedures.These devices are indicated for cemented use only. | |
| The Zimmer Unicompartmental Knee System isdesigned for use when load bearing ROM isexpected to be less than or equal to 155 degrees. | |
| Comparison to Predicate Device: | The Zimmer Unicompartmental Knee System issubstantially equivalent to the Miller/GalantePrecoat Unicompartmental Knee System in thatboth have similar indications, design (both are non-constrained, unicompartmental knee prostheses),materials and mechanical safety. Both devices areintended for cemented use only. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Performance testing completed as part of the designassurance procedure for the Zimmer Unicompart-mental Knee System and FMEA demonstrated thatthis device is safe and effective and substantiallyequivalent to the predicate devices.Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthis device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Mr. Stephen McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K033363
Trade/Device Name: Zimmer Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint Femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: IISX Dated: October 17, 2003 Received: October 21, 2003
Dear Mr. McKelvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device wforenced 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 conniner of prox to 114) works 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). and Cosmetre for (. market the device, subject to the general controls provisions of the Act. The r ou may, morely inims of the Act include requirements for annual registration, listing of general ocurem proficturing 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 If your device to such additional controls. Existing major regulations affecting your device can may or satifyer to basil at and Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actives and 1197 birding that your device complies with other requirements of the Act that I Dri has intact a actuations administered by other Federal agencies. You must or uny I vith 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 CFR in the quality systems (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality of the Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Stephen McKelvey
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter with anow you to begin manteans your must of your device of your device to a legally premaired 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 If you desire specific advice for your as 1100 of the states note the regulation entitled, the regulation entitled, Collider the Oriece or Compuner and market notification" (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premessoonsibilities under the Act from the Division of Small other general informational 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,
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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K033363
Indications for Use
510(k) Number (if known): | 033363
Device Name:
Zimmer Unicompartmental Knee System
Indications for Use:
These devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. ।
- Previous tibial condyle or plateau fractures with loss of anatomy or function. -
- Varus or valgus deformities. 。
- Revision of previous arthroplasty procedures. -
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knce System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cllayl
ion of General, Restorative Choice Boy
Page 1 of 1
Number K03363
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.