Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia: 2. inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; 3. revision procedures where other treatments or devices have failed, and, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Device Story
LINEAGE™ Acetabular System is a modular hip prosthesis component set for uncemented total hip arthroplasty. System comprises hemispherical titanium alloy shells (with/without 14° peripheral rim flare) and UHMWPE acetabular liners. Shells feature CP titanium plasma spray or porous bead coatings; options include solid, quadrant, or multi-hole configurations with threaded apical hole plugs. Liners include 0° or 15° overhangs and optional 4+mm lateralized shift; internal geometry accommodates existing cobalt chrome or ceramic femoral heads via WMT12/14, Orthomet®, or A-line tapers. Liner locks into shell via 18° male taper and peripheral ring assembly. Device used by orthopedic surgeons in clinical/OR settings to replace diseased hip joint surfaces, aiming to reduce pain and restore function. No software or electronic components.
Clinical Evidence
No clinical data provided; substantial equivalence supported by bench testing and materials data.
Technological Characteristics
Materials: Titanium alloy shell, UHMWPE liner, CP titanium plasma spray or porous bead coating. Design: Hemispherical shell with 14° flare option; 0°/15° liner overhangs; 4+mm lateralized shift option. Interface: 18° male taper and peripheral ring locking mechanism. Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory/inflammatory degenerative joint disease (e.g., osteoarthritis, rheumatoid arthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), functional deformity correction, revision procedures, or treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
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.
Submission Summary (Full Text)
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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LINEAGE™ Acetabular System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
ROAD
3800
July 11, 2000
Ehab M. Esmail Senior Regulatory Affairs Associate
LINEAGETM Acetabular System
Metal/ Polymer Acetabular Components
21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II Orthopedics/87/LPH
## Device Product Code and Panel Code:
## DEVICE INFORMATION
### A. INTENDED USE
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; 3.
- revision procedures where other treatments or devices have failed, and, র্ব
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Image /page/0/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
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## 000013
The LINEAGETM Acetabular System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
#### B. DEVICE DESCRIPTION
The LINEAGE™ Acetabular System consists of metal acetabular shells and UHMWPE acetabular liners.
The LINEAGE™ Acetabular Shell will be available in a hemispherical titanium allov shell with and without a 14° peripheral rim flare. The shells will be coated with commercially pure titanium plasma spray or porous beads.
Design features of the LINEAGE™ Acetabular Shell are summarized below:
- · Total hemispherical design
- · Hemispherical design with 14° flare
- · Coated with CP Ti plasma spray or porous beads
- · Solid, quadrant, and multi-hole options
- · Threaded apical hole plug
The LINEAGE™ Acetabular Liners will be available with a 0° and 15° overhangs with/without a 4+mm lateralized shift. The Liner's internal geometry will be intended to be used with our existing femoral heads manufactured from cobalt chrome or ceramic with WMT12/14 taper, Orthomet® taper and A-line taper. The LINEAGE™ Liner's external geometry will be designed to accept the LINEAGE™ Acetabular Shells.
Design features of the LINEAGE™ Acetabular Liner are summarized below:
- · 360° liner overhang positioning options
- · Features an 18° male taper and peripheral ring assembly to lock the liner into the acetabular shell
- · The lip of the 15° liner will be machined to 210°
- · The inserts will be offered with 0°and 15° overhangs
- · The inserts will also be offered with a 4+mm lateralized shift
- · Internal diameter will have a 2mm chamfer to minimize impingement.
The thinnest part of any UHMWPE articulating insert will be greater than 4 mm if attached to a metal or ceramic backing.
#### C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of the LINEAGE™ Acetabular System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the LINEAGE™ Acetabular System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
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#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 2000
Mr. Ehab M. Esmail Senior Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K002149
Trade Name: Lineage™ Acetabular System Regulatory Class: II Product Code: LPH Dated: July 13, 2000 Received: July 17, 2000
Dear Mr. Esmail:
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). 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 (OS) 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.
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Page 2 - Mr. Ehab M. Esmail
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
vonne R. Vochner
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
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Page ***_ of _***
510(k) Number (if known): K002149
LINEAGE™ Acetabular System Device Name:
Indications For Use:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following concitions:
- l ) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5) with head involvement that are unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daine R. Lochner
(Division Sign-Off) Division of General Restorative Devices 510(k) Number 4002147
Prescription Use h U (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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.
