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. - Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. - Press-fit femoral stems and acetabular cups are intended for press-fit fixation. - Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Device Story
The Exactech InteGrip Acetabular Shells are orthopedic implants for total hip arthroplasty. These titanium alloy shells are designed for press-fit fixation in the acetabulum. The device modifications include the addition of outer diameter cut-outs for optional augment attachments and a revision version featuring 9 or 12 holes for adjunctive screw fixation. Used by orthopedic surgeons in clinical settings, the device provides a stable prosthetic socket for the hip joint. The shell serves as a mechanical component to restore joint function and mobility in patients with degenerative hip conditions. The design maintains compatibility with existing Exactech hip system components.
Clinical Evidence
Bench testing only. Engineering analyses were performed to evaluate the structural integrity of the shell modifications, specifically assessing stress distribution related to the addition of screw holes and cut-outs for augment attachments.
Technological Characteristics
Titanium alloy acetabular shells; press-fit fixation; features include outer diameter cut-outs for augments and 9 or 12 screw holes for revision applications; gamma radiation sterilization (SAL 10^-6); 10-year shelf life.
Indications for Use
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, and revision of failed reconstructions with sufficient bone stock.
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® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness
OCT 1 1 2012
Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
> Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Amy Taulbee Contact: Regulatory Affairs Specialist
Date: September 11, 2012
# Trade of Proprietary or Model Name(s): Exactech® InteGrip™ Acetabular Shell
Exactech® InteGrip™ Revision Acetabular Shell
Common Name: Total Hip Arthroplasty - Acetabular Components
#### Classification Name:
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Class II, Product Code LPH)
Information on devices to which substantial equivalence is claimed:
Trade of Proprietary Model Name Manufacturer 510(k) Number Novation® Crown Cup™ with InteGrip™ K102975 Exactech, Inc
#### Indications for Use:
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.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
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# Exactech® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
### Device Description:
The proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells are modifications to the Novation Crown Cup with InteGrip acetabular shell devices cleared through premarket notification #K102975.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- . Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical i locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (10 years) .
- Packaging and sterilization materials and processes (gamma radiation . sterilization to a sterility assurance level of 10th).
This submission proposes the following design change:
- Addition of cut-outs on the outer diameter to accommodate optional augment . attachments.
- . Addition of InteGrip Revision Acetabular Shells with 9 or 12 holes, depending on shell size, for additional adjunctive screw fixation.
#### Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells to the predicate Novation Crown Cup with InteGrip acetabular shells:
- Engineering analyses to evaluate stress on shell with screw holes and cut-outs. .
- Evaluation to assess InteGrip Revision Acetabular Shell screw hole number and ● placement.
- Evaluation to assess cut-out placement on the acetabular shells. .
The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
11
2012
Exactech. Inc. % Ms. Amy Taulbee Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K122798
K122796
Trade/Device Name: Exactech InteGrip Acetabular Shell, Exactech InteGrip Revision Acetabular Shell
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis
Regulatory Class: II Product Codes: LPH, LZO, KWZ, JDI Dated: September 11, 2012 Received: September 12, 2012
Dear Ms. Taulbee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications forcenced in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that hat to been 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, cherely mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trease now, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may of subject to 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 I lease be devilsed that I Dr i resumes of your device complies with other requirements of the Act that I Dri has made a actorized administered by other Federal agencies. You must or any I odolar battler and a media ments, including, but not limited to: registration and listing (21
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Page 2 - Ms. Amy Taulbee
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Exactech® InteGrip™ Acetabular Shells Special 510(k) - Indications for Use
510(k) Number: K122798
Device Name: Exactech® InteGrip™ Acetabular Shells
### 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.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
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 - use another page if needed.
### Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter G. Oblein for Anton Dmitriev
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122798
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.
