Wright Medical Group, Inc.

A Global Orthopaedic Medical Device Company

We are a global orthopaedic medical device company specializing in the design, manufacture, and marketing of reconstructive joint devices and biologics. Wright's product offerings include large joint implants for the hip and knee; extremity implants for the hand, elbow, shoulder, foot and ankle; and both synthetic and tissue-based bone graft substitute materials.

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Wright Medical Group, Inc.

Two Fundamentally Solid Platforms

EXTREMITIES and BIOLOGICS

40%

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ORTHO-RECON

60%

Foot & Ankle Product Portfolio - Most comprehensive & innovative

INBONE® Total Ankle

CHARLOTTE™ CLAW® 3.5mm Implant

BIOFOAM® Wedge

LIS FRANC® Plate

ORTHOSPHERE® Implant

SWANSON® Hammer Toe Implant

CHARLOTTE™ Snap-Off Screw

GRAFTJACKET® Ulcer Repair Matrix

LPT® Toe Implant

MTP® Plate

DARCO® BOW Plate

BIO-ARCH® Implant

ENDO-FUSE® Rods and Beams

CHARLOTTE™ Compression

CHARLOTTE™ CLAW® 2.7mm Implant

CHARLOTTE™ Jones Fracture Screw

DART-FIRE® Screws

CHARLOTTE™ 3.0 MUC Screw

DARCO® Screws

SWANSON Great Toe DARCO®

RPS Plate

DARCO® MPJ Plate

DARCO® LPS Plate

DARCO® PIA Plate

DARCO® DPS Plate

ORTHOLOC® Plate

CHARLOTTE 7.0 MUC Screw

AM® Surgical Endoscopic Blade

SIDEKICK® Stealth Fixation

CORETRAK® Tube Fixator

ORTHOLOC® Plate

SIDEKICK® Fixation

VALOR® NAIL Fixation

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GRAFTJACKET® Graft

EVOLVE® Implant

MICRONAIL® Implant

SWANSON® Finger Implant

RAYHACK® Radial Malunion

RAYHACK® Ulnar Shortening

EVOLVE® Plate

Upper Extremity Product Portfolio - Legacy Leadership In Niche Segments

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Ortho Recon – Innovative Knee Portfolio

ADVANCE Medial Pivot 10+ Years of clinical success

Medial-Pivot Kinematics

MIS Instrumentation

Cementless Fixation

Patient-Specific Instruments

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Ortho Recon – Innovative Hip Portfolio

Innovative & Comprehensive Acetabular Systems

CONSERVE® Total with BFH® Technology Hip System

Confidence with Stability.

CONSERVE® PLUS Total Hip

Resurfacing

Modular Hip Systems

Resurfacing & BFH Modularity Bearing Options

DYNASTY® Acetabular with BIOFOAM®

CANCELLOUS TITANIUM™

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BACKUP SLIDES

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Quality System

•  Global Quality System Certifications Ø ISO 13485:2003 Ø ISO 9001:2008

•  AATB Accredited Tissue Bank

•  FDA Establishment Registration #1043534

Quality System Overview

We will meet or exceed the expectations of our customers by complying with requirements,

by maintaining the effectiveness of the quality management system, by training employees, and

by designing and building quality into our products.

QualityPolicy

Quality Manual

•  Fostering Device Innovation – DeNovo reforms to the regulatory pathway for

lower-risk novel devices with no 510k option, but which do not warrant the PMA requirement for higher-risk devices

– 510(k) program reform: •  CDRH plan to incorporate new scientific information into

regulatory decision making •  Draft guidance on Device Modifications: Deciding When to

Submit a 510(k) for a Change to an Existing Device •  Refuse to Accept Guidance •  E-Copy Draft FDA Guidance

•  Implementation of UDI in labeling

FDA Initiatives …

•  Approval Challenges –  510(k)

Recent Trends

Standard of care in question Slower reviews- Spending total review time allowed before generating additional questions Increase in 510(k) conversion (Specialà Traditional) based on supportive data (eg. Test data, adverse event reports) Additional scrutiny of pre-clinical data Device intended for use in Class II and Class III applications must be split into 2 separate 510k filings. Ex. Hip 510ks now require duplicate filings (MoM vs MoP, CoP)

Reviewers recent enforcement related to E-Copy and Refuse to Accept Draft Guidance Historical performance (Corrective Fixes)

Corrective Fixes

Device launched

Fixes made and intent to launch

Adverse events w/ root cause

Original device recalled, obsoleted, or continued to be sold

•  Not eligible as Special 510k since data review req’d

•  How to address corrective fix in the filing? •  Typically want sponsor to be able to replicate the

failure mode observed clinically •  Demonstrate that comparatively the modified device

should not fail in similar capacity •  Demonstrate that subject device is equivalent to ‘non-

defective’ device

Pre- Clinical Data Bench testing not demonstrating equiv. to predicate. Subject not performing as well.

•  New patient population within scope of intended use/indications for use (possibly a specific indication for use)

•  New technological characteristics that may have

clinical impact (e.g. device affects surrounding bones)

•  Device performs below level of predicate device on the bench and clinical ramifications are not known/cannot be predicted in an animal model

•  Approval Challenges –  510(k) –  Letter to the File

Device modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device •  1997 Guidance vague and

requires interpretation •  2011 draft guidance was closed

for comments, but later dropped by FDA

•  Fewer changes qualify - Ex. Sizes outside of cleared range require 510k regardless of worst case determination

•  FDA scrutiny of LTF process expected during Quality audits

Recent Trends

•  Approval Challenges –  510(k) –  LTF –  Instruments

Enforcement of inclusion in PMA /510k filing “Unique instruments” take on classification of device:

Recent Trends

•  Approval Challenges –  510(k) –  LTF –  Instruments –  Customs

• Strict FDA interpretation of current guidance •  “One-of-a-kind” device limited to physician or dentist

•  If another company makes device, it is “generally available” / not custom

•  Device that could be used for >1 patient is not custom

•  Modification to an existing device (shorter, fatter, left-handed, etc) is “customized,” not custom, and requires a pre-market submission

• Burden of proof lies with manufacturer • Increase of Compassionate Use requests to due to strict interpretation of policy. • New guidance delayed by FDA

Recent Trends

•  Approval Challenges –  510(k) –  LTF –  Instruments –  Customs –  Labeling

Lack of FDA guidance for new communication methods (eg. Social Media guidance delayed) General vs Specific claims Text Requirement in Device Labeling

•  All symbols on outer package label must be accompanied by text on the outer package label.

Fair & balanced promo Final guidance on the implementation of UDI

Recent Trends

International Trends

•  Country of Origin identification •  Limited Global government resources (reviewers) •  Re-registration of devices licensed before early 2000’s

—causing approval delays (Latin America) •  Increased requests for additional data to support new

product registrations and license renewals •  Strict adherence to test standards (mechanical,

biocompatibility of final implants) •  EU: New regulations to impact CE Marking •  Canada: Uncertainty from Health Canada regarding

licensing of instruments (regulations vague on “grouping”)

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Wright Initiatives • Review of company-wide policies and procedures to ensure continued compliance to evolving regulations (domestic and global)

• Delays in review have required the adjust of internal timelines for new product launches, as well as global renewals

• Review and streamline of product portfolio. Product redeployment initiated for R.O.W. markets.

• Communication with FDA to enlist least burdensome approach for UDI implementation

• Active involvement with industry groups (eg . AdvaMed, OSMA)