AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of the AcuMatch Integrated Hip System are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion. AcuMatch Press-Fit Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.
Device Story
AcuMatch Press-Fit Femoral Components are orthopedic implants used in total hip arthroplasty. The system consists of titanium alloy (Ti-6Al-4V) femoral stems with trapezoidal cross-sectional geometry, secondary distal tapers, and optional calcar collars. Components are available with or without hydroxyapatite (HA) or plasma coatings. The device is implanted by an orthopedic surgeon in a clinical/OR setting. The surgeon performs a press-fit insertion into the femoral canal; non-HA coated versions may also be used with bone cement. The implant replaces the femoral head and neck to restore joint function and mobility. Clinical benefit includes pain relief and improved hip function for patients with degenerative joint disease or fractures. The device is provided sterile via gamma radiation.
Clinical Evidence
Bench testing only. Performance verified via fatigue testing of production-quality parts and rotating beam fatigue tests of wrought and forged materials. Results compared against predicate MCS design, demonstrating superior fatigue performance. No clinical trial data presented.
Indicated for skeletally mature patients undergoing primary total hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative hip conditions, or proximal femoral fractures. Also indicated for revision of failed reconstructions with sufficient bone stock and to restore mobility after previous fusion. Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders preventing hip joint control, or patients where weight, age, or activity level suggests early system failure.
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
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Image /page/0/Picture/0 description: The image shows the word "Exactech" in white letters on a black background. The word is in a bold, sans-serif font. To the left of the word is a white circle with a gap in the upper right quadrant. The image is simple and clean, with a focus on the company name.
Koo214/
2320 NW 66TH COURT GAINESVILLE, FL 32653
#### 352-377-1140 FAX 352-378-2617
## AUG 1 6 2000
# Exactech® AcuMatch™ Integrated Hip System Press-Fit Femoral Components
# 510(k) Summary of Safety and Effectiveness Special 510(k)
Sponsor:
Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|--------|--------------------|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Contact:
Gary J. Miller, Ph.D. V.P. of Research and Development
Date:
July 14, 2000
Section 4 Page 1 of 5
{1}------------------------------------------------
## 510(k) Summary of Safety and Effectiveness Special 510(k)
LWJ
II
not specified
#### Classifications / Proprietary Names:
Classification Name:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (Femoral Component)
Trade / Proprietary Model Names:
AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit
Product Code:
C.F.R. Section:
Device Class:
Classification Panel: Orthopedic
Classification Name:
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (Femoral Component)
Trade / Proprietary Model Names:
AcuMatch P-Series Press-Fit Plasma / HA AcuMatch P-Series Press-Fit / HA AcuMatch L-Series Press-Fit / HA
Product Code:
not specified
Device Class:
C.F.R. Section:
II
MEH
Classification Panel: Orthopedic
{2}------------------------------------------------
### 510(k) Summary of Safety and Effectiveness Special 510(k)
### Legally Marketed Devices for Substantial Equivalence Comparison:
The Exactech AcuMatch Press-Fit Stems are made of similar materials and are of a similar design to other legally marketed femoral components, most notably the Exactech MCS femoral components:
| Model | Manufacturer | 510(k) Number | Product Code |
|-----------------------|------------------------------|---------------|--------------|
| MCS | Exactech | 921113 | LPH |
| MCS/HA | Exactech | 990197 | MEH |
| | | | |
| Perfecta | Wright Medical<br>Technology | ---------- | ---------- |
| Synergy HA | Smith & Nephew | ---------- | ---------- |
| Synergy Press-Fit | Smith & Nephew | ---------- | ---------- |
| Secur-Fit HA | Osteonics | ---------- | ---------- |
| APR Fully<br>Textured | Sulzer | ---------- | ---------- |
#### Device Description
### Indications for Use:
AcuMatch Press-Fit Stems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, dhenmatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-taunatio degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred tratment. Components of AcuMatch Integrated Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is prased ond to restore mobility resulting from previous fusion.
{3}------------------------------------------------
## 510(k) Summary of Safety and Effectiveness Special 510(k)
AcuMatch Press-Fit Femoral Components are intended to be used in press-fit applications. Components without the hydroxyapatite (HA) coating may also be used with bone cement.
#### Contraindications:
AcuMatch Press-Fit Femoral Components are 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 of the system.
The indications/contraindications for use for the proposed AcuMatch Press-Fit Femoral Components are identical to those of our predicate Exactech MCS and MCS/HA Femoral Components (#K921113,#K990197).
| Material | Composition |
|---------------------|-----------------------------------|
| Inner / Outer Trays | PETG - 0.040" thickness |
| Tray Lids | Spun-Bonded Olefin - Tyvek® |
| Inserts | Medium grade LD45 Foam |
| Box | Heavy weight cardboard |
| Outer Shrink-Wrap | Clear, Light-Weight Plastic |
| Shipping Cartons | Heavy-weight Corrugated Cardboard |
Packaging Materials:
Utilization and implantation instructions are included in the package insert provided with each product. The name, size, dimension, material, lot, serial number and sterility status are indicated on the labeling.
Sterilization Specifications:
Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 100
{4}------------------------------------------------
# 510(k) Summary of Safety and Effectiveness Special 510(k)
#### Substantial Equivalency Comparison:
Like the Exactech MCS models (ref. #K921113 and #K990197), the proposed AcuMatch models are composed of titanium alloy (Ti-6Al-4V), have a trapezoidal crosssectional geometry, secondary distal tapers, optional calcar collars and optional hydroxyapatite (HA) coatings. The HA coating available on the AcuMatch models is identical to the one used for the predicate MCS component.
The differences in design features between the proposed AcuMatch and predicate MCS models include changes in the manufacturing technique, dimensional modifications to the neck region, a new sizing differential and changes to the surface presentations.
These design changes for the proposed AcuMatch models do not affect the intended use of the device and do not alter the fundamental scientific technology of the device.
In addition, the AcuMatch Press-Fit Stems have basic design features in common with femoral components designed by other orthopedic companies. These include but are not limited to Wright Medical's "Perfecta", Osteonic's "Secur-Fit HA", Sulzer's "APR Fully Textured" and Smith & Nephew's "Synergy" press-fit designs.
#### Performance Information:
Functional tests were conducted to verify that the performance of the AcuMatch Press-Fit stems would be adequate for anticipated in vivo loading. This performance data included fatigue testing of production quality parts, rotating beam fatigue tests of the wrought and forged materials, and vendor material certifications. The AcuMatch results exceeded those of the predicate MCS design which has a clinical history in excess of 7 years with no reported stem failures.
Based on the fatigue performance data, material specifications and design considerations, it is felt that the Exactech AcuMatch Press-Fit femoral components are substantially equivalent to the Exactech MCS femoral components (#K921113, #K990197).
> Section 4 Page 5 of 5
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
# AUG 1 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Simpson Regulatory Representative Exactech 2320 NW 66th Court Gainesville, Florida 32653
Re: K002141
Trade Name: AcuMatch P-Series Press-Fit, Plasma and HA Coated Femoral Components AcuMatch L-Series Press-Fit and HA Coated Femoral Components Regulatory Class: II Product Code: LWJ and MEH Dated: July 14, 2000 Received: July 17,2000
Dear Ms. Simpson:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
{6}------------------------------------------------
Page 2 - Ms. Lisa Simpson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnostions on the promotion and advertising of your device, (301) 594-4037. Additionally, for quest 21 (1) 594-4639. Also, please note the regulation prease connect the Office or Compilance en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Jour responsibility the number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
e R. lochner
M 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
{7}------------------------------------------------
### Indications for Use
510(k) Number:
1002141
Device Name:
AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit
AcuMatch P-Series Press-Fit Plasma/HA AcuMatch P-Series Press-Fit/HA AcuMatch L-Series Press-Fit/HA
#### Intended Use / Indications:
AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of the AcuMatch Integrated Hip System.are.also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
AcuMatch Press-Fitt Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.
#### Contraindications:
AcuMatch Press-Fit Femoral Stem Components are 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 of the system.
Please do not write below this line - use another page if needed.
| | | | Concurrence of CDRH, Office of Device Evaluation (ODE) Vochines. |
|------------------|-----|----|------------------------------------------------------------------|
| | | | (Division Sign-Off) |
| | | | Division of General Restorative Devices |
| | | | 510(k) Number K002141 |
| Prescription Use | yes | or | Over the Counter Use No |
Section 3Page 1 of 1
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.
