All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation. AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation. Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
Device Story
Total hip system components including femoral stems, femoral heads, and acetabular liners; used in orthopedic surgery to replace diseased or damaged hip joints. Femoral stems feature trapezoidal geometry and distal taper; femoral heads utilize 12/14 Euro-style taper for compatibility. Components implanted by orthopedic surgeons in clinical/OR settings. System provides structural support and articulation for hip joint; restores mobility; relieves pain associated with degenerative conditions. Modifications include 12/14 taper design, 36mm head/liner options, and geometric adjustments to femoral neck. Sterile, single-use implants.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and engineering evaluations to verify performance of modified components.
Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip problems, or proximal femoral fractures. Also indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions with sufficient bone stock, and restoration of mobility after fusion.
Regulatory Classification
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.
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**Exactech**®
K041906
P. 1/4
2320 NW 66TH COUF GAINESVILLE, FL 3265
352 377 1140 FAX 352-378-2617
## Exactech® 12/14 Total Hip System
SEP 1 0 2 )04
# 510(k) Sunnmary of Safety and Effectiveness Special 510(k)
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|--------|--------------------|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Gary J. Miller Contact: Exec. V.P. of Research & Development
August 17, 2004 Date:
Rev. 08 17 04
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## Exactech® 12/14 Total Hip System
#### 510(k) Summary of Safety and Effectiveness Special 510(k)
#### Trade or proprietary or model name(s):
AcuMatch 12/14 Press-Fit Femoral Stems AcuMatch 12/14 CoCr Femoral Heads AcuMatch A-Series Acetabular Component (36mm I.D.)
## Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|-------------------------------------------------|----------------|
| K030236 | AcuMatch P-Series Press-Fit Porous Femoral Stem | Exactech, Inc. |
| K002141 | AcuMatch P-Series Press-Fit Plasma Femoral Stem | Exactech, Inc. |
| | AcuMatch L-Series Press-Fit Femoral Stem | |
| K862234 | Exactech CoCr Femoral Head | Exactech, Inc. |
| K964262 | Exactech CoCr Femoral Head | Exactech, Inc. |
| K993082 | AcuMatch A-Series Acetabular Liners | Exactech, Inc. |
#### INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
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## Exactech® 12/14 Total Hip System
#### 510(k) Summary of Safety and Effectiveness Special 510(k)
#### Special 510(k) Device Modifications
The femoral stem tapers on predicate Exactech total hip system components were modified from a proprietary Exactech design to a "12/14 Euro-style" design. A 36 mm line of femoral heads and mating acetabular liners was also added to the system. As such, each component covered in the "Special 510(k)" represents a design change to an Exactech predicate device.
#### 12/14 CoCr Femoral Heads
12/14 CoCr Femoral Heads are composed of cobalt chromium alloy conforming to ASTM F1537 (warm worked condition). The femoral stem taper connection was modified from a proprietary Exactech taper design to a 12/14 Euro-style taper design. This allows for compatibility with Exactech 12/14 femoral stem components.
## AcuMatch 12/14 Press-Fit Femoral Stems
AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper. The P-Series model is available with a porous bead or plasma-spray surface enhancement. The L-Series model has a corundum finish. Options include collared and non-collared versions and hydroxapatite (HA) coating. The components are intended for press-fit applications.
The AcuMatch Press-Fit femoral stems were modified as follows:
- The femoral neck length was decreased by 4mm .
- The femoral neck geometry was shifted medially by 1.5 mm .
- The geometry of the insertion hole feature was modified from a dimple to the oblong . slot.
- "12/14" Laser-etching was added to the face of the femoral stem taper. .
- A "High Offset" version was added to the P-Series Plasma product line. .
## 36 mm AcuMatch A-Series Acetabular Liners
The A-Series 36mm liners are a line extension to the current A-Series product line. The new liners are designed to mate with A-Series Acetabular "shell" components. This includes the A-Series Porous Acetabular Shells (K993082) and the A-Series Corundum Acetabular Shell (K000242). Each liner has a size designation (H, J, or K) that matches it to the correct mating shell component. The new 36 mm A-Series Acetbular liners are designed to articulate with the Exactech 12/14 36mm cobalt chromium femoral heads.
All Exactech implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10°6.
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1. 4/4
# Exactech® 12/14 Total Hip System
## 510(k) Summary of Safety and Effectiveness Special 510(k)
#### Conclusion:
Conclusion.
Testing and engineering evaluations were conducted to verify that the performance of the new Exactech 12/14 Total Hip System components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes extending from its body. The bird is positioned above a wavy line, possibly representing water or a horizon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Gary J. Miller, Ph.D. Executive Vice President of Research & Development Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K041906 Trade/Device Name: Exactech 12/14 Total Hip System Regulation Number: 21 CFR 888.3358, 888.3353, 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Code: LPH, LZO, MEH, LWJ, JDI Dated: August 17, 2004 Received: August 19, 2004
Dear Dr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered provises in 113) 2011 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter for , market the device, subject to the general controls provisions of the Act. The 1 ou may, dicrores, mains 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 If your device is exactive (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 r 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 or any I 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
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Page 2 - Gary J. Miller, Ph.D.
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. 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 premained notification " 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echeral 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,
Mark N Millerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Exactech®, Inc.
# Exactech 12/14 Total Hip System
# Indications for Use
#K041906 510(k) Number:
#### INDICATIONS
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals All Exacteen Inp Bystems are mais replacement due to osteoarthritis, theumatoid
undergoing primary surgery for hip replacement due to osteoarthritis, i undergoing primary surgery for mp rophoses.
arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for arthritis, osteonectosis, post trainates where prosthetic replacement is determined by treatment of proximal femoral mactared with of Exactech Hip Systems are also the surgeon as the proferod a oaimes.
potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) Fress-In acclabular shells and process at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
| Prescription Use | X | or | Over the Counter Use ________ |
|------------------|---|----|-------------------------------|
|------------------|---|----|-------------------------------|
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Rev. 08 18 04 | |
|----------------------|---------|
| <b>510(k) Number</b> | K041906 |
| | Section 3<br>Page 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.
