The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following: Rheumatoid arthritis with pain Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) Correction of functional deformity Fractures of the humeral head Traumatic arthritis Revision of other devices if sufficient bone stock remains . All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.
Device Story
Modular shoulder prosthesis; includes humeral stems, humeral heads, and all-polyethylene glenoid components. Humeral stems provide proximal fixation; variable length/shape accommodates natural humeral geometry; 0-3 mm head adjustment. Humeral heads (spherical/non-spherical) allow neutral/offset positioning via offset taper. Glenoid component (cemented) features 2-3 pegs. Used in orthopedic surgery for total shoulder replacement or hemiarthroplasty. Physician-operated in clinical/surgical settings. Provides increased mobility/stability and pain relief for patients with disabled shoulder joints. Components are single-use; humeral stem allows cemented or cementless fixation.
Indicated for patients with intact/reconstructable rotator cuff requiring shoulder joint replacement due to rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, traumatic arthritis, or revision of prior devices with sufficient bone stock.
Regulatory Classification
Identification
A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
Axiom Orthopaedics Shoulder Resurfacing System (K061862)
Submission Summary (Full Text)
{0}------------------------------------------------
K071147
# 510(k) Summary for Nexa Orthopedics Total Shoulder System
#### SPONSOR 1.
Nexa Orthopedics, Inc. 285 West Side Avenue Suite 251 Jersey City, NJ 07305
Contact Person: Peter Verrillo Telephone: 201-377-9129
Date Prepared: April 04, 2007
#### DEVICE NAME 2.
| Proprietary Name: | Nexa Orthopedics Total Shoulder System | | |
|----------------------|---------------------------------------------------------------------------|--|--|
| Common/Usual Name: | Total Shoulder Replacement | | |
| Classification Name: | Shoulder joint metal/polymer non-constrained cemented<br>prosthesis; | | |
| | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis; | | |
| | Shoulder joint humeral (hemi-shoulder) metallic<br>uncemented prosthesis. | | |
#### 3. PREDICATE DEVICES
- Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, . K032507)
- Tornier Aequalis Shoulder System (K063081) .
- Axiom Orthopaedics Shoulder Resurfacing System (K061862) .
{1}------------------------------------------------
#### 4. DEVICE DESCRIPTION
The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa system.
#### 5. INTENDED USE
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional glenoid component. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff where it will provide increased mobility and stability as well as reduced pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- Rheumatoid arthritis with pain .
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and . avascular necrosis)
- . Correction of functional deformity
- Fractures of the humeral head .
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cemented or cementless use, while the glenoid is intended for cemented use only.
{2}------------------------------------------------
#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Nexa Total Shoulder System and the predicate devices are equivalent in that they all consist of humeral stems, humeral heads, and optional all polyethylene glenoid components. The proposed humeral stems, humeral heads, and glenoid components are equivalent to their predicates in that they are composed of TikAlaV, CoCrMo, and Ultra High Molecular Weight Polyethylene respectively.
Similarly, both the proposed products and their predicate devices have been designed to mimic the normal humeral canal, humeral head, or glenoid sizing and shape appropriately. Therefore, both the proposed and predicate devices are available in a variety of stem, head, and glenoid sizes.
Furthermore, as with their predicates, the Nexa humeral stem may be press fit, or cemented, while the glenoid is for cemented use only.
#### 7. PERFORMANCE TESTING
The Nexa Orthopedics Total Shoulder System components have been evaluated with respect to the following standards:
- ASTM F2009-00 Standard Test Method for Determining the Axial . Disassembly Force of Taper Connections of Modular Prostheses
- . ASTM F2028-02 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.
- ASTM F1378 05 Standard for Shoulder Implants ●
- ASTM 1044 05 Standard Test Method for Shear testing of Calcium . Phosphate Coatings and Metal Coatings
- . ASTM F-1537-00 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants
- ASTM F1147 -- 05 Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- . ASTM F 136 REV A Standard Specification for Wrought Titanium -6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F648-04 Standard Specification for Ultra-High-Molecular-Weight . Polyethylene Powder and Fabricated Form for Surgical Implants
{3}------------------------------------------------
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, flowing design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2007
Nexa Orthopedics, Inc % Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K071147
Trade/Device Name: Nexa Orthopedics Total Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT, HSD Dated: April 4, 2007 Received: April 24, 2007
Dear Ms. McNamara-Cullinane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
{4}------------------------------------------------
### Page 2 - Ms. Mary McNamara-Cullinane
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 marketed predicate device 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 (240) 276-0120 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehly
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## Indications for Use
510(k) Number (if known):
Device Name: Nexa Orthopedics Total Shoulder System
Indications for Use:
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- . Rheumatoid arthritis with pain
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- . Correction of functional deformity
- . Fractures of the humeral head
- . Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|----------------------------------------------|---|--------|---------------------------------------------|
|----------------------------------------------|---|--------|---------------------------------------------|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Nexa Orthopedics 510(k) Total Shoulder System | April 4, 2007 | |
|-----------------------------------------------|---------------|---------|
| 510(k) Number | K071147 | Page vi |
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.
