K Number
K210167
Device Name
DELTA XTEND Reverse Shoulder System
Date Cleared
2021-02-19

(29 days)

Product Code
Regulation Number
888.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only. The DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: severe arthropathy and/or; a previous failed joint replacement and/or: fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.
Device Description
The DELTA XTEND™ Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated: Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes
More Information

Not Found

No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and coating, not algorithmic performance.

Yes.
This device is an implantable prosthesis used in total or hemi-shoulder arthroplasty procedures to treat severe shoulder conditions, which directly addresses a medical condition.

No

The device is described as a "Reverse Shoulder System" intended for use in "total or hemi-shoulder arthroplasty procedures," which are surgical interventions, not diagnostic procedures. The "Intended Use / Indications for Use" section focuses on treatment of specific conditions rather than identifying or analyzing them.

No

The device description explicitly states it is comprised of multiple humeral and glenoid implant components, which are physical hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint in patients with specific conditions. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens like blood or tissue.
  • Device Description: The device is described as a system of humeral and glenoid implant components, which are physical implants for surgical procedures.
  • Performance Studies: The performance studies mentioned are related to the physical properties and testing of the implant materials (HA coating, porosity), not diagnostic performance metrics like sensitivity or specificity.
  • Anatomical Site: The anatomical site is the shoulder joint, where the implant is surgically placed.

IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.

N/A

Intended Use / Indications for Use

The DePuy DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with:
-severe arthropathy and/or;
-a previous failed joint replacement and/or:
-fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternate methods of treatment are unsatisfactory

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

Product codes (comma separated list FDA assigned to the subject device)

PHX, HSD, KWS

Device Description

The DELTA XTEND™ Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated:

Humeral Implants: Modular humeral stems Modular epiphysis
Glenoid Implants: Metaglenes

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder joint, proximal humerus, glenoid

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following tests were performed on the DELTA XTEND™ Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

  • . HA coating testing on shelf-aged product per
    o ISO-13779-3: Implants for surgery - Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity.
    ASTM F1854 Standard test method for stereological evaluation of porous coatings on o medical implants.
    ASTM E2109 Standard test methods for determining area percentage porosity in thermal o sprayed coatings.

NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE.

The subject device DePuy DELTA XTEND™ Reverse Shoulder System is substantially equivalent to the predicate DePuy Synthes DELTA XTEND™ Reverse Shoulder System (K062250, K071379, K120174, K192448).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192448, K071379, K120174, K062250

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
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.”

0

February 19, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

DePuy Orthopaedics Inc. Megan Bernier Regulatory Affairs Specialist 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K210167

Trade/Device Name: DELTA XTEND™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWS Dated: January 15, 2021 Received: January 21, 2021

Dear Megan Bernier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K210167

Device Name

Trade Name: DELTA XTEND™ Reverse Shoulder System

Indications for Use (Describe) DELTA XTEND™ Reverse Shoulder System

The DePuy DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with:

-severe arthropathy and/or;

-a previous failed joint replacement and/or:

-fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternate methods of treatment are unsatisfactory

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
NameDePuy Orthopaedics, Inc.
Address700 Orthopaedics Drive
Warsaw, Indiana 46581-0988
Phone number651-325-1178
Fax number612-435-2372
Establishment
Registration Number1219655
Name of contact personMegan Bernier
Email of contact personMbernie1@its.jnj.com
Date prepared15, January 2021
Name of device
Trade or proprietary
nameDELTA XTEND ™ Reverse Shoulder System
Common or usual
nameShoulder Prosthesis
Classification nameShoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis;
Shoulder joint metal/polymer semi-constrained cemented prosthesis
ClassClass II
Classification panelOrthopedics
Regulation21 CFR 888.3690, 888.3660
Product Code(s)PHX, HSD, KWS
Legally marketed
device(s) to which
equivalence is claimedDELTA XTEND ™ Reverse Shoulder System (DePuy: K062250,
K071379, K120174, K192448)
Reason for 510(k)
submissionThe purpose of this submission is to extend the current approved shelf life of 5
years to 10 years
Device descriptionThe DELTA XTEND™ Reverse Shoulder System is currently cleared
and marketed by DePuy Synthes and is comprised of multiple humeral
and glenoid implant components. These are provided as separate,
standalone devices and may be used in conjunction to form a total
shoulder prothesis. This submission is pertinent to only those system components which are HA coated:
Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes
Intended use of the deviceThe DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.
Indications for useThe DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: severe arthropathy and/or; a previous failed joint replacement and/or: fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

5

6

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE
COMPARED TO THE PREDICATE DEVICE
Characteri
sticsSubject Device:
DELTA XTEND™
Reverse Shoulder
SystemPredicate
Device:
DELTA XTEND™
Reverse Shoulder
System
(K192448)Predicate Device:
DELTA XTEND™
Reverse Shoulder
System (K071379,
K120174)Primary Device:
DELTA XTEND™
Reverse Shoulder
System (K062250)
Intended
UseReverse shoulder
arthroplastyReverse shoulder
arthroplastyReverse shoulder
arthroplastyReverse shoulder
arthroplasty
Material
Humeral
Implants
(Modular
Humeral
Stem,
Modular
Epiphysis)Titanium Alloy
(Ti6Al4V) with
plasma sprayed HA
coatingTitanium Alloy
(Ti6Al4V) with
plasma sprayed HA
coatingTitanium Alloy
(Ti6Al4V) with plasma
sprayed HA coatingTitanium Alloy
(Ti6Al4V) with
plasma sprayed HA
coating
Material
Glenoid
Implants
(Metaglene)Titanium alloy
with HA coatingTitanium alloy
with HA coatingTitanium alloy
with HA coatingTitanium alloy
with HA coating
Modular, without
cement,
composed of an
epiphysis and a
humeral stem
made out of
titanium and
coated with
hydroxyapatite.Modular,
without cement,
composed of an
epiphysis and a
humeral stem
made out of
titanium and
coated with
hydroxyapatite.Modular, without
cement, composed
of an epiphysis
and a humeral
stem made out of
titanium and
coated with
hydroxyapatite.Modular, without
cement,
composed of an
epiphysis and a
humeral stem
made out of
titanium and
coated with
hydroxyapatite.
Fixation
Humeral
Implants
(Modular
Humeral
Stem,
Modular
Epiphysis)The epiphysis is
available in
standard or long
version and in
two sizes in order
to be able to adapt
as well as
possible to the
human anatomy.
The distal stem is
available in
several diameters
to maximize the
adaptability of
humeral canal.The epiphysis is
available in
standard or long
version and in
two sizes in
order to be able
to adapt as well
as possible to the
human anatomy.
The distal stem
is available in
several diameters
to maximize the
adaptability of
humeral canal.The epiphysis is
available in
standard or long
version and in two
sizes in order to be
able to adapt as
well as possible to
the human
anatomy. The
distal stem is
available in
several diameters
to maximize the
adaptability of
humeral canal.The epiphysis is
available in
standard or long
version and in two
sizes in order to be
able to adapt as
well as
possible to the
human anatomy.
The distal stem is
available in
several diameters
to maximize the
adaptability of
humeral canal.

7

8

| Fixation
Glenoid
Implants
(Metaglene) | The Glenoid
Implant is
comprised of a
glenosphere that
is fixed on the
metaglene by a
conical joint and a
central pin.
The metaglene is
coated with
hydroxyapatite
and is fixed inside
the bone with 4
screws.
This submission
pertains to the
metaglene
component of the
Glenoid Implant
only. | The Glenoid
Implant is
comprised of a
glenosphere that
is fixed on the
metaglene by a
conical joint and
a central pin.
The metaglene is
coated with
hydroxyapatite
and is fixed
inside the bone
with 4 screws.
This submission
pertained to the
metaglene
component of
the Glenoid
Implant only. | The Glenoid
Implant is
comprised of a
glenosphere that is
fixed on the
metaglene by a
conical joint and a
central pin.
The metaglene is
coated with
hydroxyapatite
and is fixed inside
the bone with 4
screws. | The Glenoid
Implant is
comprised of a
glenosphere that
is fixed on the
metaglene by a
conical joint and
a central pin.
The metaglene is
coated with
hydroxyapatite
and is fixed
inside the bone
with 4 screws. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterile
Method | Gamma (single use
only) | Gamma (single use
only) | Gamma (single use
only) | Gamma (single use
only) |
| Packaging | | | | |
| | Both systems
utilized a double
sterile barrier.
The Humeral
Stems are placed
into a foam
envelope or poly
protector, placed
into a nylon
pouch that is
vacuumed sealed
and then placed
into a PETG tray
sealed with Tyvek
lid stock. | Both systems
utilized a double
sterile barrier.
The device is
placed into a foam
envelope, placed
into a nylon pouch
that is vacuumed
sealed and then
placed into a
PETG tray sealed
with Tyvek lid
stock. | Both systems
utilized a double
sterile barrier.
The device is
placed into a
foam envelope,
placed into a
nylon pouch that
is vacuumed
sealed and then
placed into a
PETG tray sealed
with Tyvek lid
stock. | |
| | Both systems
utilized a double
sterile barrier.
The Humeral
Stems are placed
into a foam
envelope or poly
protector, placed
into a nylon
pouch that is
vacuumed sealed
and then placed
into a PETG tray
sealed with
Tyvek lid stock. | | | |
| | The Modular
Epiphysis and
Metaglene
components are
placed into an
inner PETG
blister fitted with
a polyurethane
insert and then
sealed with Tyvek
lid stock. The
inner blister for
all components is
then placed into
an outer PETG
blister sealed with
Tyvek lid stock. | | | |
| | The Modular
Epiphysis and
Metaglene
components are
placed into an
inner PETG
blister fitted with
a polyurethane
insert and then
sealed with
Tyvek lid stock.
The inner blister
for all
components is
then placed into
an outer PETG
blister sealed
with Tyvek lid
stock. | | | |
| | Shelf Life | 10 years | 5 years | 5 years |

9

10

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed on the DELTA XTEND™ Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

  • . HA coating testing on shelf-aged product per
    • o ISO-13779-3: Implants for surgery - Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity.
    • ASTM F1854 Standard test method for stereological evaluation of porous coatings on o medical implants.
    • ASTM E2109 Standard test methods for determining area percentage porosity in thermal o sprayed coatings.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject device DePuy DELTA XTEND™ Reverse Shoulder System is substantially equivalent to the predicate DePuy Synthes DELTA XTEND™ Reverse Shoulder System (K062250, K071379, K120174, K192448).