The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The Glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Inflammatory degenerative joint disease such as rheumatoid arthritis; - Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; - Cuff tear arthropathy.
Device Story
SMR CTA Humeral Heads are modular orthopedic implants for total or hemi-shoulder arthroplasty; designed to articulate with glenoid bone or prosthetic glenoid component. Device consists of CoCrMo humeral head with lateral flange; coupled to humeral body and stem via adaptor tapers. System includes humeral stems (cemented/uncemented), humeral bodies, and UHMWPE glenoid components. Used by orthopedic surgeons in clinical/OR settings. Adaptor tapers adjust center of rotation and offset to optimize soft tissue tension and joint stability. Device provides mechanical replacement for damaged shoulder joint surfaces; restores joint function and reduces pain in patients with degenerative disease or fractures.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing, including static pull-out testing of modular connections and range of motion simulations on worst-case components.
Technological Characteristics
Materials: Humeral heads (CoCrMo, ISO 5832-12/ASTM F1537), stems/bodies/adaptors (Ti6Al4V, ISO 5832-3/ASTM F1472), glenoids (UHMWPE, ISO 5834-2/ASTM F648). Modular design with Morse-taper coupling. Stems available in 60mm (double conicity) and 80mm (triple conicity) lengths. Glenoid features central peg and cement pockets. Mechanical fixation via cement or press-fit. Non-software device.
Indications for Use
Indicated for patients with shoulder disability due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), acute humeral head fractures untreatable by fixation, or cuff tear arthropathy.
Regulatory Classification
Identification
A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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K110847
#### JUL 15 2011 Summary of Safety and Effectiveness
Date: March 14, 2011
Manufacturer: Limacorporate S.p.A. · Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: 574-527-4220
| Product | Product Code | Regulation and Classification Name |
|--------------------------|--------------|----------------------------------------------------------------------------------------------|
| SMR CTA Humeral<br>Heads | HSD | Shoulder joint humeral (hemi-shoulder) metallic<br>uncemented prosthesis per 21 CFR 888.3690 |
| | KWS | Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis per 21 CFR 888.3660 |
### Description:
The SMR CTA Humeral Heads are made from CoCrMo (ISO 5832-12 / ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The articulating surface is polished. The only difference between the SMR CTA Humeral Heads and the humeral heads cleared in K100858 is the addition of a lateral flange to better accommodate the rotator cuff tear arthropaty patient.
The SMR CTA Humeral Heads are intended to be coupled to the humeral body by means of specific adaptor tapers. Humeral bodies are then assembled by taper coupling with humeral stems. When used in total shoulder replacement. the SMR CTA Humeral Heads are coupled with glenoid components. Humeral stems, humeral bodies, adaptor tapers and glenoid components are the same cleared in K100858 and K101263.
SMR CTA Humeral Heads can be used with both cemented and uncemented stems. Glenoid components are intended for cemented use only.
The device descriptions for the adaptor tapers, humeral bodies, humeral stems and glenoid components cleared via K100858 and K101263 are repeated here in italic typing for an understanding of the complete system.
Two designs of humeral stems are available: the first one is intended for uncemented use while the second one is intended for cemented use only.
Traditional 510(k)-SMR CTA Humeral Heads March 14, 2011
Section 5 - Page 17 of 181
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be 'KII 8847'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal proximal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6A14V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.
Humeral bodies are available in two designs. The first one is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented and in uncemented applications. Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).
They are coupled with the humeral stem via a female Morse-taper connection stabilized with a locking screw. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.
Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V (ISO 5832-3, ASTM F1472). They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and to give the required offset to the humeral head in order to achieve the correct tensioning to the soft tissues, optimizing joint stability.
The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The surface is polished in order to reduce wear.
Glenoids are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation. Six cement pockets are also incorporated on the back surface of the glenoid to enhance cement fixation.
Intended Use: The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder ioint arthroplasty. The Glenoid is intended for cemented use only.
Traditional 510(k)-SMR CTA Humeral Heads March 14, 2011
Section 5 - Page 18 of 181
Page 2 of 3
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## K110847
Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Treatment of acute fractures of the humeral head that cannot be treated with other . fracture fixation methods:
- . Cuff tear arthropathy.
## Predicate Devices:
SMR Shoulder System (Limacorporate. K100858) and SMR Uncemented Shoulder System (Limacorporate, K101263):
Global Advantage Extended Humeral Heads (DePuy, K000575).
## Comparable Features to Predicate Device(s):
The SMR CTA humeral heads are similar to the predicate devices in terms of intended use, indications, design and materials. The CTA humeral heads and the predicates are all intended for partial or total primary shoulder joint replacement. The CTA humeral heads are intended for cemented or uncemented use, depending on the components they're coupled with (i.e. cemented or uncemented stems).
The design of CTA humeral heads is the same as the Global Advantage Extended Humeral Heads.
The components of the SMR CTA humeral heads are manufactured from the same materials as the predicate devices.
## Non-Clinical Testing:
The SMR CTA humeral heads have the same modular coupling of the Standard humeral heads cleared via K100858. The modular connection has undergone static pull-out testing. All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. A simulation of the Range of Motion has been performed to ensure the device design does not overly limit range of motion. The testing results demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads to the predicate device(s).
Traditional 510(k) -SMR CTA Humeral Heads March 14, 2011
Section 5 - Page 19 of 181
Page 3 of 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Limacorporate S.p.A % Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590-696
Jul 1 5 2011
Re: K110847
Trade/Device Name: SMR CTA Humeral Heads Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: June 20, 2011 Received: June 28, 2011
Dear Ms. Hastings:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 warranties. We remind you, 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 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 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
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## Page 2 - Ms. Cheryl Hastings
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.
Eil Keith
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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# KIT 8847
510(k) Number (if known): Unknown
Device Name: SMR CTA Humeral Heads
Indications for Use:
## SMR CTA Humeral Heads Indications for Use
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The Glenoid is intended for cemented use only.
Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; ●
- Treatment of acute fractures of the humeral head that cannot be treated with other . fracture fixation methods;
- Cuff tear arthropathy. .
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerm
(Division Sigh-Off) (Division of Surgical, Orthopedic, Orthopedic,
Division of Surgices Division of Surges
K110847
510(k) Number
Page 1 of 1
Traditional 510(k) - SMR CTA Humeral Heads March 14, 2011
Company Confidential Section 4 - Page 15 of 181
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.
