Key Observations from Published Literatureon Bone Response in Hand & Wrist Surgery

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WHY IMPLANT MATERIAL MATTERS

In hand and wrist procedures, anchors are placed within thin cortices, narrow canals, and confined joint spaces.

Bone response to implant material—including osteolysis, cystic change, or radiolucency—may influence construct stability, imaging interpretation, and long-term clinical outcome.

OSTEOLYSIS FOLLOWING THE USE OF PEEK SUTURE ANCHORS IN HAND & WRIST SURGERY

Chen et al., J Hand Surg Am, 2025.

Clinical study quantifying tunnel enlargement around PEEK suture anchors in the hand and wrist.

Osteolysis, defined as tunnel enlargement greater than 30% over time, was observed in 27% of anchors (12 of 45) at final follow up, with a mean tunnel size increase of 51.5%.

ADDITIONAL ADVERSE REACTIONS FROM PUBLISHED LITERATURE

Representative published reports include:

1. Galano et al., 2010 — inflammatory response and osteolysis following a bioabsorbable anchor in a finger
2. Giannikas et al., 2009 — aseptic foreign-body reaction and osteolysis associated with a suture anchor in a digit
3. Zaidenberg et al., 2016 — severe osteolysis after bioabsorbable anchor use in carpal ligament repair
4. Schrumpf et al., 2011 — foreign-body reaction, synovitis, and osteolysis related to poly-L-lactic acid anchors in the wrist

Beyond PEEK, published case reports have documented foreign-body reactions and osteolytic bone changes associated with certain bioabsorbable suture anchor materials when used in small bones of the hand and wrist.

Reported observations include:

1. Local inflammatory or foreign-body reactions surrounding anchors
2. Progressive osteolysis and cystic bone changes
3. Bone loss developing months after implantation
4. Cases requiring implant removal or secondary surgery

Key takeaway from the literature:

Bone response varies by material composition, degradation profile, and local biomechanics, particularly in small-bone fixation.

Published literature demonstrates that both inert and certain bioabsorbable anchor materials may be associated with osteolytic or inflammatory bone responses in hand and wrist surgery.

Material Choice & OSSIOfiber^®

MATERIAL CHOICE MATTERS

In small-bone fixation, even subtle biologic responses to implant material can have outsized consequences. Surgeons must consider not only initial fixation strength, but how an implant interacts with bone over time.

Published long-term preclinical and clinical studies of OSSIOfiber^® technology demonstrate controlled bio-integration, bone replacement, and absence of adverse inflammatory response.

BIO-INTEGRATIVE FIXATION: EVIDENCE OF SAFE BONE INTEGRATION

Cole et al., Scientific Reports, 2024

Anterior Cruciate Ligament Reconstruction in a Translational Model in Sheep using Biointegrative Mineral Fiber Reinforced Screws

Key Findings translated for Hand & Wrist relevance:

1. Gradual mesenchymal ingrowth and new bone formation
2. Secure fixation without irritancy or adverse inflammatory response
3. OSSIOfiber^® anchor substantially eliminated by 2 years, replaced by bone
4. No cystic formation or inflammatory reaction observed

CLINICAL BONE INTEGRATION EVIDENCE (SMALL-BONE ANATOMY)

Štalc et al., Foot & Ankle Surgery, 2022.

Fiber-Reinforced Fixation Implant for PIP Joint Arthrodesis — 2-Year Follow-Up

Clinical Relevance:

Demonstrates controlled bio-integration in small bones with limited tolerance for inflammatory response — directly relevant to hand & wrist anatomy.

Key Clinical Observations:

• 96% radiographic fusion at 2 years
• No cyst formation or fluid accumulation
• Mean bio-integration score: 9.7 / 10
• No device-related adverse events

Key takeaway from the literature:

Bone response varies by material composition, degradation profile, and local biomechanics, particularly in small-bone fixation.

OSSIOfiber^® BIO-INTEGRATION TIMELINE

Gradual bio-integration with replacement by native bone and absence of adverse inflammatory response.¹

WHAT MAKES OSSIOfiber^® DIFFERENT

Proven materials engineered into a proprietary strong and bio-integrative matrix.

OSSIOfiber^® 2.5 MM SUTURE ANCHOR

A small-footprint, bio-integrative solution designed for soft-tissue fixation where bone preservation matters.

Key Features:

• Small Footprint Anchor optimized for small-bone repairs
• Superior pull-out strength vs. market-leading 2.4 mm anchor (12-week preclinical data)
• Disposable, sterile instrument pack for streamlined OR workflow
• Single-loaded with 1.4 mm UHMWPE tape for efficient suture passage

Ordering Information:

Description	Product Code
OSSIOfiber® Suture Anchor 2.5mm, 1.4mm Blue Tape w/ Needles	OF1032552S
OSSIOfiber® Suture Anchor 2.5mm, 1.4mm Wt/Blue Tape w/ Needles	OF1032553S
OSSIOfiber® Suture Anchor 2.5mm w/ Snare	OF1032554S
OSSIO 1.8mm Instrument Pack For 2.5mm Suture Anchor	THN00509
OSSIO 2.0mm Drill Bit For 2.5mm Suture Anchor*	THN00511
Standalone 1.4mm Wt/Blue Tape, Box of 6	THN00514

Indications for Use:

The OSSIOfiber^® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Specific indications are listed below:

Shoulder

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee

Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Joint Capsule Closure

Hand/Wrist

Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

Hand/Wrist

Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

Elbow

Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)