Cemented Aequalis Reversed prosthesis: It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation. When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis. When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components. Uncemented Aequalis Reversed prosthesis: It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation. When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis. When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Device Story
Aequalis Reversed Shoulder Prosthesis is a semi-constrained shoulder joint replacement system. It functions by medializing the center of rotation, lengthening the deltoid muscle lever arm to restore shoulder mobility in patients with non-functional rotator cuff muscles. The system consists of humeral and glenoid components. This modification introduces glenoid base plates with a central threaded post and TiPS coating. Used in clinical settings by orthopedic surgeons. The device provides a mechanical replacement for the shoulder joint, potentially improving patient function and reducing pain. If glenoid bone stock is insufficient during primary surgery or revision, components can be adapted into a non-reversed hemi-prosthesis using an adaptor and union screw to avoid humeral component revision.
Clinical Evidence
Bench testing only. Pull-out testing (ASTM E1586) compared new and cleared glenoid base plates in foam blocks to verify equivalent fixation strength. Cadaveric testing confirmed proper instrument and implant use, achieving primary fixation without scapular fracture or major peri-operative complications.
Technological Characteristics
Semi-constrained shoulder prosthesis. Glenoid base plate material: Ti6Al4V (ISO 5832-3). Coating: TiPS (ASTM F 1580). Fixation: Uncemented glenoid (4 screws), optional cemented or uncemented humeral components. Features threaded central post (20-50mm length). Sterilization: Terminal sterilization.
Indications for Use
Indicated for patients with functional deltoid muscle requiring total shoulder replacement for pain relief and disability reduction due to arthropathy associated with massive, non-repairable rotator cuff tears; also indicated for prosthetic revisions in the same patient population.
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human profiles facing right. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier SAS Mrs. Magalie Hennequin Regulatory Project Manager 161 rue Lavoisier 38334 Montbonnot Saint Martin FRANCE
Re: K132285
Trade/Device Name: Aequalis Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: November 21, 2013 Received: November 22, 2013
Dear Ms. Hennequin:
This letter corrects our substantially equivalent letter of December 5, 2013.
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
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Page 2 - Ms. Magalie Hennequin
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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 yours,
# Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K132285
Device Name: Aequalis Reversed Shoulder Prosthesis
Indications For Use:
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
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 ofCDRH, Office ofDevice Evaluation (ODE)
Page 1 of 1
Tornier
Page 5 of69
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K132285 (1/5)
# Implants Chirurgica
## 510 (k) Summary of Safety and Effectiveness information Traditionnal 510(k) Premarket Notification - Aequalis Reversed Shoulder Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name AEQUALIS Reversed Shoulder Prosthesis Trade name: Shoulder Prosthesis Common name: Classification name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
2) Submitter TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
3) Company contact Tornier Mrs Magalie Hennequin Regulatory project Manager 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 03 Fax: 00 33 4 76 61 35 59 e-mail : magalic.hennequin@tornier.com
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
5) Equivalent / Predicate device
Aequalis Reversed Shoulder Prosthesis, TORNIER SAS. K030941, K050316. K061439, K081059, K 100142 Aequalis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873
#### 6) Device description
The Aegualis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
K132285
Image /page/3/Picture/14 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and has a unique design, with the top bar extending slightly beyond the vertical stem. The logo is black and white, with the "T" and the outline of the hexagon being black against a white background. The logo appears to be a simple, yet distinctive mark, possibly representing a company or brand with a name starting with the letter "T".
S.A.S. au capital de 35 043 008 € TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 FRANCE CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
DEC 0.5 2013
Section 5 - Page 1/ page 5
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K132285 (2/5)
Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition Therefore, the usual Loar of Salersed Shoulder Prosthesis is intended to accomplish these and to reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification consists in the addition of glenoid base plates with central threaded post and a new coating.
## 7) Materials
The glenoid base plate is manufactured from Titanium alloy.
The TiPS coating conforms to the ASTM standard F 1580.
The coating is performed by Eurocoating or APS according to their Master File MAF1760 (for Eurocoating) and MAF 628 (for APS).
#### 8) Indications
#### Cemented Acqualis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cutf-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis. the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
#### Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures. the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range. the use of the heniprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Section 5 - Page 2/ page 5 K132285 Tél. : 33 (0)4 76 61 35 00 S.A.S. an capital de 35 043 008 € TORNIER S.A.S. SIRET : 070 501 275 000 21 Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
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## 9) Summary of technological characteristics
| Main features of<br>system characteristics | Acqualis Reversed II<br>Shoulder System<br>(new components) | Acqualis Reversed II<br>Shoulder System | Aequalis Ascend flex | Reverse Shoulder<br>Prosthesis | |
|--------------------------------------------|-------------------------------------------------------------|-----------------------------------------|------------------------------------------------------|------------------------------------|-------------------------------|
| Material | Glenoid base<br>plate | Ti6A14V | Ti6Al4V or Ti6Al4V<br>+ HA | Ti6A14V | Alloy titanium |
| Standard | Glenoid base<br>plate | ISO 5832-3 | ISO 5832-3 | ISO 5832- 3. | - |
| Coating<br>material | Glenoid base<br>plate | TiPS Coating | Hydroxylapatite | | |
| Coating<br>standard | Glenoid base<br>plate | ASTM F 1580 | ASTM F 1185 | ASTM F 1580 | - |
| Method of fixation<br>Glenoid component | | Uncemented | Uncemented | Uncemented | Uncemented |
| Glenoid base plate<br>diameter | | 25mm or 29mm | 25mm or 29mm | NA in reversed<br>configuration ** | |
| Post | Post design | Threaded post | Press fit post | NA in reversed<br>configuration ** | Threaded post |
| | Post length | 20 mm to 50mm | 15mm or 25mm | NA in reversed<br>configuration ** | |
| | External<br>diameter | 9.5mm +/- 0.05mm | 8.3mm +/- 0.05mm | NA in reversed<br>configuration ** | |
| | Diameter of<br>bottom of the<br>thread | 6.5mm<br>+0.35/-0.05mm | NA | NA in reversed<br>configuration ** | |
| Terminal sterilization | | Yes | Yes | Yes | Yes |
| Manufacturers | | Tornier | Tornier | Tornier | DJO |
| K-number | | Pending | K030941<br>K050316<br>K061439<br>K081059*<br>K100142 | K122698 | K041066<br>K051075<br>K092873 |
The indication for use, the manufacturing principle and the sterilization process are similar to the cleared Aequalis Reversed II glenoid base plate.
The design, the coating and the method of fixation of the pending Aequalis Reversed II glenoid base plate is substantially similar to the predicates.
K132285
Section 5 - Page 3/ page 5
Image /page/5/Picture/8 description: The image shows a logo with a letter T inside of a hexagon. The letter T is stylized with a thick top bar and a thick vertical line. The hexagon is outlined in black and appears to be a regular hexagon. The logo is simple and geometric.
S.A.S. au capital de 35 043 008 € Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 161. rue Lavoisier R.C.S. : 070 501 275 38334 MONTBONNOT CEDEX CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 18330 MONTBONNOT SAINT MARTIN - FRANCE
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K132285 (4/5)
Two technological features are different for the new components of the Aequalis Reversed Prosthesis from the predicates:
- The dimension of the post, .
- The design of the post.
The new length of the post length allows to the surgeon to choose the length adapted to the patient's morphology (bone volume) so that the post rest on the bone.
In comparison of the recommended drilled hole diameter of the pending Aequalis Reversed base plate and the predicate, we can see that the pending Reversed base plate is equivalent with the predicates concerning the risk of glenoid's fracture.
To demonstrate that the anchorage of the base plate on the bone is equivalent independently of the post design a pull out testing was conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate.
### 10) Non-clinical testing
Pull out testing and cadaver testing was performed.
The aim of pull out testing (E1586) is to show the equivalence between the new Aequalis Reversed base plates and the cleared models independently of the post design.
Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations.
To demonstrate the equivalence between the new glenoid base plate and the cleared glenoid base plate the resistance in Pull-out has to be equivalent.
The aim of cadaver testing is to ensure proper use of instruments and implants.
The result shows that primary fixation has been achieved without scapular fracture or other major peri-operative complications.
### 11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis to the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis can be demonstrated on the following grounds, according to the FDA 's Guidelines for Substantial Equivalence Decision Making Process:
To
16
38
K132285
TORNIER S.A.S. Tčl. : 33,(0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
Section 5 - Page 4/ page 5
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K132285 (5/5)
# Implants Chirurg
- The new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis are compared to the predicate devices.
- The new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis have the . same intended use as the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis.
- Major technological characteristics are equivalent between the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis and the predicate devices:
- Equivalence of general features -
- Equivalent means of fixation -
- Equivalent materials -
Therefore, in the light of the above information, the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis are found to be equivalent to the predicate devices.
K132285
Image /page/7/Picture/10 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be constructed from thick lines, giving it a blocky appearance. The hexagon provides a border around the 'T', creating a contained and geometric design.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MON'TBONNOT SAINT MARTIN - FRANCE
Section 5 - Page 5/ page 5
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.
