4D BiologiXAllograft Tissue

About Us

Tissue science,
without the guesswork.

4D BiologiX supplies human allograft tissue to surgeons and surgical facilities: demineralized bone matrix in the handling formats a case actually calls for, mineralized cancellous allograft, and dual-layer amniotic membrane for surgical application. Alongside them sits a synthetic ceramic bone graft, for the cases where donor tissue is not the right answer.

The catalogue is built around a simple idea — the biology should be consistent, and the choice you make in the operating room should be about handling. A defect that needs to be packed wants fibers. A defect that needs to be filled and irrigated wants putty or crush. A contained void that needs to be bridged wants a strip or a cube. Same tissue science, formatted for the procedure.

9

Products in the catalogue

6

Demineralized bone matrix formats

35

Individual sizes and volumes

10⁻⁶

Sterility assurance level

How We Work

Four things we hold to.

01

Format follows the procedure

Nine products across four families, differentiated by how they handle rather than by marketing tier. Fibers pack, putty shapes, crush resists irrigation, strips and cubes recover their dimensions after compression, and a synthetic ceramic covers the cases that call for no donor tissue at all.

02

Recovered and processed under 21 CFR Part 1271

All tissue is recovered from screened donors and processed as human cells, tissues and cellular and tissue-based products regulated solely under Section 361 of the Public Health Service Act — minimally manipulated and intended for homologous use.

03

Documented sterility, documented tolerance

Terminal sterilization to a sterility assurance level of 10⁻⁶ where the format allows it, with dimensional tolerances published on the product page rather than held back for the spec sheet.

04

Open and go

Room temperature storage across the catalogue and no reconstitution step for the putty and crush formats. Fewer things to get wrong on the back table, and nothing that has to be planned around a freezer.

What We Supply

Bone graft formats

Fiber, crush, putty, cube, strip and a 70/30 fiber–granule blend

Cancellous particle ranges

1–4 mm and 4–10 mm, in volumes to 30 cc

Amniotic membrane sizes

Five dual-layer formats, 1 × 1 cm through 4 × 8 cm

Surgical specialties served

Spine, orthopedics, podiatry, robotic, colorectal, urology, OB/GYN, general and thoracic surgery

Regulatory Position

Section 361 HCT/Ps, handled as such.

Every product in the catalogue is a human cell, tissue, or cellular and tissue-based product regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. Each is minimally manipulated and intended for homologous use.

Products in this category do not require, and do not have, FDA pre-market clearance or approval. We say so plainly on every product page rather than leaving it to a footnote — the regulatory pathway is a fact about the product, and your value analysis committee will ask.

Complete documentation — establishment registration, accreditation, donor screening and eligibility statements and sterilization validation summaries — is available through the partner portal or on request.

Get In Touch

For pricing, availability, documentation or case support, send us the details and we will come back to you.

Telephone
877-44D-Biologix
Address
1060 Holland Dr, STE G2Boca Raton, FL 33487
Contact us