NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
K043101 · Zimmer, Inc. · JWH · Mar 7, 2005 · Orthopedic
Device Facts
Record ID
K043101
Device Name
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
Applicant
Zimmer, Inc.
Product Code
JWH · Orthopedic
Decision Date
Mar 7, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.
Device Story
NexGen MIS Tibial Components are semiconstrained, nonlinked condylar knee prostheses; part of the NexGen system. Used in total knee arthroplasty to replace damaged joint surfaces; intended for cemented fixation. Operated by orthopedic surgeons in clinical/hospital settings. Device provides mechanical stability and joint articulation for patients with severe knee pain/disability. Output is a restored joint configuration; aids clinical decision-making by addressing structural joint failure and pain. Benefits include improved mobility and pain relief.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Semiconstrained, nonlinked condylar knee prosthesis. Metal/polymer construction. Designed for cemented use. Part of the NexGen system. No software or electronic components.
Indications for Use
Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, post-traumatic joint loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knees lacking stability in flexion. Intended for cemented use only.
Regulatory Classification
Identification
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Predicate Devices
NexGen Precoat Stemmed Tibial Plates and Stem Extensions (K933785)
NexGen Locking Screws and Taper Stem Plugs (K991581)
NexGen Porous, Uncemented Femoral and Tibial Baseplate Components (K031061)
Submission Summary (Full Text)
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K043101
## MAR 7 - 2005
### Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: (574) 371-8083<br>Fax: (574) 372-4605 |
| Date: | November 8, 2004 |
| Trade Name: | <i>NexGen</i> <sup>®</sup> Complete Knee Solution <i>MIS</i> ™ Tibial<br>Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial polymer/metal/<br>polymer semi-constrained cemented prosthesis<br>21 CFR § 888.3560 |
| Predicate Devices: | <i>NexGen</i> Precoat Stemmed Tibial Plates and Stem<br>Extensions, manufactured by Zimmer, Inc.,<br>K933785, cleared January 30, 1995.<br><i>NexGen</i> Locking Screws and Taper Stem Plugs,<br>manufactured by Zimmer, Inc., K991581, cleared<br>July 30, 1999.<br><i>NexGen</i> Porous, Uncemented Femoral and Tibial<br>Baseplate Components, manufactured by Zimmer,<br>Inc., K031061, cleared October 3, 2003. |
| Device Description: | The <i>NexGen MIS</i> Tibial Components are part of the<br><i>NexGen</i> system of semiconstrained, nonlinked<br>condylar knee prostheses. |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to:<br><ul><li>Rheumatoid arthritis, osteoarthritis,<br/>traumatic arthritis, polyarthritis.</li><li>Collagen disorders, and/or avascular<br/>necrosis of the femoral condyle.</li><li>Post-traumatic loss of joint configuration,</li></ul> |
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# K643101
and the comments of the comments of the comments of the comments of
| | particularly when there is patellofemoral<br>erosion, dysfunction or prior patellectomy<br>Moderate valgus, varus, or flexion<br>deformities.<br>- The salvage of previously failed surgical<br>attempts or for a knee in which satisfactory<br>stability in flexion cannot be obtained at the<br>time of surgery.<br>This device is intended for cemented use only. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Except for minor modifications, MIS Tibial<br>Components are identical to the predicate devices.<br>The modifications do not change the intended use o<br>the fundamental scientific technology. The device<br>is packaged and sterilized using the same materials<br>and processes. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br><br>Performance testing completed as part of the design<br>assurance process demonstrated that this device is<br>safe and effective and substantially equivalent to th<br>predicate device. |
| | Clinical Performance and Conclusions:<br><br>Clinical data and conclusions were not needed for<br>this device. |
and the same of the same of the same of the same
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
MAR 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K043101
KU43101
Trade/Device Name: NexGen® Complete Knee Solution MISTM Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Enee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II
Product Code: JWH Dated: February 4, 2005 Received: February 7, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wE have teviewed your bected. 9 10(2) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1776, the excordance with the provisions of the Federal Food, Drug, de necs mat have been reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelors, mains of the Act include requirements for annual registration, listing of general controls provision 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 is elassinod (over as controls. Existing major regulations affecting your device can may oc subject to sach additions, 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 1 that FDA has made a determination that your device complies with other requirements of the Act that I Drivias intatutes and regulations administered by other Federal agencies. You must of any I caefal statuted and regisments, including, but not limited to: registration and listing (21 econfire with an the Not 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of evense (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin marketing your article equivalence of your device to a legally premarket notification. The PDA inding of substantial organism 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 active en other and and the regulation entitled, Colliact the Office of Complance at (210) = 16 = 21 807.97). You may obtain Mission of the release to premantonibilities under the Act from the Division of Small be other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octrise http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Melleman
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# K043101
### Indications for Use
510(k) Number (if known):
#### Device Name:
NexGen® Complete Knee Solution MIS™ Tibial Components
### Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- evice is indicated for patients withis, traumatic arthritis, polyarthritis.
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, ।
- Rheumatord artifulis, osteourantials, necrosis of the femoral condyle. -
- Collagen disorders and or avascular necrosis of when there is patellofemoral । erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. l
- Moderate Valgus, Varas of Trekton ugical attempts or for a knee in which ﺖ I he saivage of previously fance surgious atthe fime of surgery.
This device is intended for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
710(k) Number
K043101
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
