K964262 · Exactech, Inc. · JDI · Dec 27, 1996 · Orthopedic
Device Facts
Record ID
K964262
Device Name
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
Applicant
Exactech, Inc.
Product Code
JDI · Orthopedic
Decision Date
Dec 27, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Exactech Total Hip System: 22mm Femoral Head is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
Device Story
The Exactech 22mm Femoral Head is a prosthetic component for total hip arthroplasty. It is a cobalt chromium alloy head available in three neck lengths (-3mm, +2mm, +8mm) and a 22mm diameter. The device is implanted by an orthopedic surgeon during hip replacement surgery. It mates with a femoral stem via an internal taper lock and articulates against an acetabular component (typically UHMWPE). The device restores hip joint function in patients with degenerative joint disease or failed prior reconstructions. Clinical benefit is derived from the established biocompatibility and mechanical performance of cobalt chromium alloys in orthopedic bearing applications.
Clinical Evidence
No clinical data provided for this specific device. Evidence relies on historical clinical literature (Charnley et al., 1973, 1975; Mirra et al., 1976) and laboratory biocompatibility studies (Turner et al., 1973) demonstrating the safety and performance of cobalt chromium alloys in orthopedic applications.
Technological Characteristics
Material: Wrought high strength cobalt chromium (ASTM F90-87). Design: 22mm diameter, three neck lengths (-3mm, +2mm, +8mm). Interface: Internal taper lock for femoral stem connection. Sterilization: Gamma irradiation (SAL 10^-6) per AAMI guidelines.
Indications for Use
Indicated for skeletally mature patients undergoing primary total hip replacement for osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, or post-traumatic degeneration; also for revision of failed reconstructions with sufficient bone stock. Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders preventing hip control, or patients with weight, age, or activity levels expected to cause early system failure.
Regulatory Classification
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).
Predicate Devices
Orthomet
Zimmer-Charnley Type Total Hip
Exactech® Femoral Heads
Submission Summary (Full Text)
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K964262
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DEC 27 1996
# 510(K) Summary
## SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION IN THE PREMARKET NOTIFICATION FOR THE EXACTECH TOTAL HIP SYSTEM: 22mm FEMORAL HEAD
Exactech, Inc.
Establishment Registration Number 1038671
The Exactech 22mm Femoral Head is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, the 22mm Femoral Head is of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to:
- Orthomet
- Zimmer-Charnley Type Total Hip
- Exactech® Femoral Heads
In addition, Exactech provided to the FDA, design drawings, and material specifications characterizing the 22mm Femoral Head
The Food and Drug Administration, in rules listed in the Federal Register, Friday, September 4, 1987, as Hip Joint Metal/Polymer Semi-Constrained Prosthesis, Section 888.3350 and Docket No. 78N3075, as a class II Device.
## Design Considerations
The Exactech 22mm Femoral Head is sized in three neck lengths: short (-3mm), standard (+2mm), long (+8mm). It is available in 22mm diameter. The femoral head is made of cobalt chromium alloy, a preferred metal alloy for bearing with The Ultra High Molecular Weight Polyethylene (UHMWPE), found in the acetabular components. The femoral head mates with the femoral stem by its precise internal taper lock. In addition, its overall design is similar to those used by Charnley and others since the early introduction of Total Hip Arthroplasty and assures adequate component thickness as put forth by Bartel for such components.
## Design Parameters
The Exactech Total Hip System: 22mm Femoral Head consists of various neck lengths and is made from forged high strength cobalt chromium. The components are available in a range of sizes to fit varying anatomical requirements. The device is designed for use with all Exactech femoral components. A complete trial set and instrumentation is available to assist in accurate implantation of the prosthetic components. Design drawings are typical for such components that have been used in the industry since their introduction by Charnley in the late '60's.
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## Material Specifications
The Exactech 22mm Femoral Head is manufactured from wrought high strength cobalt chromium corresponding with ASTM F90-87.
## Biocompatibility
Cobalt Chromium has a long history of use in orthopaedic applications. Its biological response has been well characterized by a history of clinical studies (Charnley, J., Cupiz, A., “The Nine and Ten Year Results of the Low Friction Arthroplasty of the Hip”, Clinical Orthopaedics, Vol 95, No. 9, 1973.; Halley, D., Charnley, J. “Results of Low Friction Arthroplasty in Patients 30 Years of Age and Younger”, Clinical Orthopaedics, No. 112, October, 1975 and Mirra, J., Amstutz, H., Matos, M., and Gold, R., “The Pathology of Joint Tissues and Its Clinical Relevance in Prosthesis Failure”, Clinical Orthopaedics, No. 117, June, 1976) and by laboratory studies (Turner, J., Lawrence, W., and Autian, J., “Subacute Toxicity Testing of Biomaterials Using Histopathologic Evaluation of Rabbit Muscle Tissue,” Journal of Biomedical Materials Research, Vol 7, 1973. Compatibility of Biocompatibility of Materials for Total Joint Replacement”. Journal of Biomed. Mater. Research, Vol 10, No.2, 1976.). These tests include data on human and animal performance and show that the tissue exhibits excellent biocompatibility.
See Volume II for References
## Sterilization
The Exactech 22mm Femoral Head will be sterilized by gamma irradiation. The Sterility Assurance Level (SAL) is $10^{-6}$. Exactech utilizes Method 3, Protocol B from the “AAMI Guideline for gamma radiation sterilization” for the sterility dose setting and validation procedure.
## Utilization and Implantation
Selection of the Exactech Total Hip System: 22mm Femoral Head depends on the judgement of the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation by appropriate reading of the literature, and training in the operative skills and techniques required for total hip arthroplasty surgery.
## Indications
The Exactech Total Hip System: 22mm Femoral Head is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
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## Contraindications
Use of the Exactech 22mm Femoral Head is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure to the system.
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.
