← Product Code [KWS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS) · K130642
# SMR 3-PEGS GLENOIDS (K130642)
_Lima Corporate S.P.A. · KWS · Jun 12, 2013 · Orthopedic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K130642
## Device Facts
- **Applicant:** Lima Corporate S.P.A.
- **Product Code:** [KWS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS.md)
- **Decision Date:** Jun 12, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3660
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic
## Intended Use
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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: - Revision of a failed primary implant; - Cuff tear arthropathy (CTA Heads only). The Large Resection Stems (not available in the US) are indicated for oncology applications. The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
## Device Story
SMR 3-Pegs Glenoids are UHMWPE prosthetic components for cemented fixation in total shoulder replacement. Device features spherical backside with three pegs to enhance cement adhesion; articulating surface radius exceeds humeral head radius to allow superior/inferior and anterior/posterior translation. Used in clinical settings by orthopedic surgeons during shoulder arthroplasty. Provides stable glenoid articulation; restores joint function; reduces pain associated with degenerative or inflammatory joint disease. Sterile, single-use device.
## Clinical Evidence
Bench testing only. Mechanical evaluation performed per ASTM F1829 (static shear) and ASTM F2028 (dynamic loosening/disassociation). Range of motion simulation conducted. No clinical data required for substantial equivalence.
## Technological Characteristics
Material: UHMWPE. Fixation: Cemented (three-peg design). Geometry: Spherical backside, articulating surface radius > humeral head radius. Sterilization: Ethylene oxide (EtO). Shelf life: 5 years. Standards: ASTM F1829, ASTM F2028.
## Regulatory 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.”
## Predicate Devices
- SMR Cemented Shoulder System ([K100858](/device/K100858.md))
- SMR Uncemented Shoulder System ([K101263](/device/K101263.md))
- SMR CTA Humeral Heads ([K110847](/device/K110847.md))
- SMR Revision Stems ([K111212](/device/K111212.md))
- Global Shoulder Crosslink Glenoid ([K052472](/device/K052472.md))
- Glenoid Component for the Foundation Total Shoulder System ([K960906](/device/K960906.md))
## Submission Summary (Full Text)
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#### K130642 (1/4)
# . JUN 1 2 2013
# Summary of Safety and Effectiveness
Date: February 28, 2013
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Stefano Adami Regulatory Affairs Manager Phone: +390432945511
| Product | Product Code | Regulation and Classification Name |
|---------------------|--------------|------------------------------------------------------------------------------------------|
| SMR 3-Pegs Glenoids | KWS | Shoulder joint metal/polymer semi-constrained
cemented prosthesis per 21 CFR 888.3660 |
#### Description:
The SMR 3-Pegs Glenoids are made from standard UHMWPE ). They are intended for cemented fixation only.
The SMR 3-Pegs Glenoids are available in two sizes (Small and Standard). They are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.
The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.
#### Intended Use:
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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:
- Revision of a failed primary implant; .
- Cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy
Traditional 510(k) - SMR 3-Pegs Glenoids February 28, 2013
Section 5 - Page 1 of 4
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(disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
| System | | Components | Material | Use | | Available
in US |
|----------|---------|-------------------------------------------------------|---------------------------|-----|------------|--------------------|
| Anatomic | Reverse | | | Cem | Not
Cem | |
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | | |
| • | • | SMR Stems (Cementless Finned, Cementless
Revision) | Ti6Al4V | | X | • |
| • | • | SMR Large Resection stems | Ti6Al4V | X | | |
| • | • | SMR Modular Augments | Ti6Al4V | X | | |
| • | • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X | • |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X | • |
| • | | SMR Reverse HA Coated Humeral Body | Ti6Al4V+HA | | X | |
| • | | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X | • |
| • | | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X | • |
| • | • | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X | • |
| | • | SMR Glenospheres | CoCrMo | | X | • |
| | • | | Ti6Al4V | | X | |
| | • | | UHMWPE X-Lima
+Ti6Al4V | | X | |
| | • | | Ti6Al4V | | | |
| | • | SMR Connectors | Ti6Al4V | | X | • |
| | • | Reverse Liners | UHMWPE | X | X | • |
| | • | | UHMWPE X-Lima | X | X | |
| | • | | CoCrMo | X | X | |
| | • | | Alumina | X | X | |
| • | | SMR Cemented Glenoids | UHMWPE | X | | • |
| • | | SMR 3 Pegs Cemented Glenoids | UHMWPE X-Lima
UHMWPE | X | | • |
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* | • |
| • | • | | Ti6Al4V+PoroTi+HA | | X | |
| • | | SMR Metal Back Liner | UHMWPE
UHMWPE X-Lima | X* | X* | • |
| •* | | SMR Bone screws | Ti6Al4V | | X | • |
| • | • | SMR Glenoid Plates | Ti | | X | |
Traditional 510(k) - SMR 3-Pegs Glenoids February 28, 2013
Section 5 - Page 2 of 4
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#### *NOTE :
- . In the US, the SMR Metal Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- . Outside the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for uncemented use with the addition of screws for fixation.
- The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR . Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
#### Predicate Devices:
- Limacorporate SMR Cemented Glenoids included in the following cleared 510(k): .
- SMR Cemented Shoulder System (K100858); ।
- . SMR Uncemented Shoulder System (K101263);
- SMR CTA Humeral Heads (K110847); -
- SMR Revision Stems (K111212). -
- . Global Shoulder Crosslink Glenoid (DePuy, K052472);
- Glenoid Component for the Foundation Total Shoulder System (Encore DJO, . K960906).
#### Comparable Features to Predicate Device(s):
The intended use and indications for the Limacorporate SMR 3-Pegs Glenoids are similar to those of the referenced predicate devices and identical to those of the SMR cemented glenoids (K100858, K101263, K110847 - "rotator cuff tear arthropathy" and K I 1212 - "revision of a failed primary component"). As for all the referenced predicate devices where a glenoid component is used, the SMR 3-Pegs glenoids are used in total shoulder replacements and are intended for use with bone cement only.
The surface of the SMR 3-Pegs Glenoids articulating with the humeral heads and the spherical backside surface are identical to those of the already cleared SMR glenoids. As for all the referenced predicate devices, the SMR 3-Pegs glenoids have a radius of curvature greater than the radius of the articulating humeral heads. The three pegs used for the fixation by means of bone cement are very similar to those of Foundation Total Shoulder glenoid (Encore - DJO) and to the peripheral pegs of the Global Shoulder Crosslink glenoid (DePuv). The presence of grooves on the fixation peg has the same functionality (enhance cement adhesion) for SMR 3-Pegs Glenoids as for the other cemented glenoids of Limacorporate and for the Foundation Total Shoulder glenoid (Encore - DJO).
The UHMWPE used for the SMR 3-Pegs Glenoids is the same material used for the SMR System cemented glenoids (Limacorporate). The two sizes of glenoids available for the SMR 3-Pegs Glenoids have the same identical dimensions of the sizes Small and Standard of the cleared SMR cemented glenoids.
Traditional 510(k) - SMR 3-Pegs Glenoids February 28, 2013
Section 5 - Page 3 of 4
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All SMR 3-Pegs Glenoids and referenced Predicate Devices are sterile, single use devices. Sterilization of the SMR 3-Pegs Glenoids performed by means of ethylene oxide (EtO), the Sterility Assurance Level (SAL of 100), the shelf life of 5 years are identical to that of the cleared cemented glenoids of the SMR Systems.
#### Non-Clinical Testing:
The SMR 3-Pegs Glenoid has undergone mechanical tests according to ASTM F1829 (Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear) and ASTM F2028 (Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation). A Range of Motion simulation has been performed to ensure the device design does not overly limit range of motion. 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. 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 3-Pegs Glenoids to the predicate device(s).
Traditional 510(k) - SMR 3-Pegs Glenoids February 28, 2013
Section 5 - Page 4 of 4
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming its body. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter Dated: June 12, 2013
Limacorporate S.p.A. % Hastings Regulatory, LLC Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590
Re: K130642
Trade/Device Name: SMR 3-Pegs Glenoids Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: May 4, 2013 Received: May 6, 2013
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 mav 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
{5}------------------------------------------------
#### 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne -A
Mark N. Melkerson Director . Division of Orthopedic Devices Office_of Device_Evaluation_ Center for Devices and Radiological Health
Enclosure
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## 510(k) Number (if known): K130642 Device Name: SMR 3-Pegs Glenoids Indications for Use:
## SMR 3-Pegs Glenoids Indications for Use
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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 acure fractures of the humeral head that cannot be treated with other fracture fixation . methods:
- Revision of a failed primary implant; .
- . " Cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem. the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal-back-determines if the construct is cemented or uncemented.
| System | | Components | Material | Use | | Available
in US |
|----------|---------|----------------------------------------------------|------------|-----|------------|--------------------|
| Anatomic | Reverse | | | Cem | Not
Cem | |
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | | X | • |
| • | • | SMR Large Resection stems | Ti6Al4V | X | | |
| • | • | SMR Modular Augments | Ti6Al4V | X | | |
| • | • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X | • |
| • | | SMR Reverse Humeral Body | Ti6Al4V | X | X | • |
| • | | SMR Reverse HA Coated Humeral Body | Ti6Al4V+HA | X | X | • |
| • | • | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X | • |
| • | • | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X | |
| • | • | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X | |
Page 1 of 2
## Traditional 510(k) - SMR 3-Pegs Glenoids February 28, 2013
Section 4 - Page 15 of 436
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| Anatomic | Reverse | Components | Material | Cem | Not Cem | Available in US |
|----------|---------|------------------------------|---------------------------|-----|---------|-----------------|
| | • | SMR Glenospheres | CoCrMo | | X | |
| | • | SMR Glenospheres | Ti6Al4V | | X | • |
| | • | SMR Glenospheres | UHMWPE X-Lima
+Ti6Al4V | | X | |
| | | SMR Connectors | Ti6Al4V | | X | • |
| | • | Reverse Liners | UHMWPE | X | X | • |
| | • | Reverse Liners | UHMWPE X-Lima | X | X | |
| | • | Reverse Liners | CoCrMo | X | X | |
| | • | Reverse Liners | Alumina | X | X | |
| • | | SMR Cemented Glenoids | UHMWPE | X | | |
| • | | SMR 3 Pegs Cemented Glenoids | UHMWPE X-Lima | X | | |
| • | | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | | |
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* | • |
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi+HA | | X | |
| • | • | SMR Metal Back Liner | UHMWPE | X* | X* | • |
| • | • | SMR Metal Back Liner | UHMWPE X-Lima | | X | |
| •* | • | SMR Bone screws | Ti6Al4V | | X | • |
| | • | SMR Glenoid Plates | Ti | | X | |
Alumina (ISO 6474) - PoroTi Titanium Coating (ASTM F1580) - HA Hyroxyapatite Coating (ISO 13779)
*NOTE :
- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR � Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- . Outside the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for uncemented use with the addition of screws for fixation.
- The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR . Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
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)
Image /page/7/Picture/11 description: The image shows the text "Casey E. Hanley, Ph.D." above a horizontal line. Below the line, the text "Division of Orthopedic Devices" is displayed. There are some graphical elements above and below the text, but they are not clearly identifiable.
Page 2 of 2
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Section 4 - Page 15 of 436
---
**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K130642](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWS/K130642)
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