# Implant tissue traceability software that closes the loop from donor to recipient and back

> Implant tissue traceability is the record that lets a hospital or tissue bank follow a human cell or tissue product in both directions: donor to consignee or final disposition, and consignee back to the donor. FDA requires that system under 21 CFR 1271.290, built on a distinct identification code that may not contain a name, a social security number or a medical record number. Neurobird holds that code and its history.

- URL: https://neurobird.com/implanttissue/
- Product: Neurobird Implant Tissue Traceability Inspection Tracking Platform
- Niche: implant tissue traceability
- Buyer: tissue banks and hospital tissue programmes
- Status: in development, open for early access
- Updated: 2026-08-21

## What Neurobird Implant Tissue Traceability does

- Hold the distinct identification code as the primary key, without a name or a medical record number in it
- Record disposition for every unit, including product that was discarded rather than implanted
- Relate a new code to an old code when a product is reassigned, as the rule requires
- Produce the accompanying records for an audit without assembling them from four systems

## How it works

1. **Receive on the code** Every unit is booked in against its distinct identification code and the records that must accompany it, so the tracking key exists before the tissue is stored.
2. **Follow it to disposition** Storage, issue, implant or discard are all disposition events against the same unit, which is what makes the trace work in both directions.
3. **Answer a recall in minutes** A donor identifier resolves to every unit and every consignee, and a consignee resolves back to the donor, without a phone tree.

## From the source material

> As part of your tracking system, you must establish and maintain a method for documenting the disposition of each of your HCT/Ps, to enable tracking from the donor to the consignee or final disposition.

Source: law.cornell.edu, https://www.law.cornell.edu/cfr/text/21/1271.290

## Industry context

- **21 CFR 1271.290** Requires a tracking system that follows every HCT/P from the donor to the consignee or final disposition, and from the consignee back to the donor. (source: eCFR, 21 CFR 1271.290, https://www.law.cornell.edu/cfr/text/21/1271.290)
- **1 code** A distinct identification code must be created specifically for tracking, and it may not include an individual's name, social security number or medical record number. (source: eCFR, 21 CFR 1271.290, https://www.law.cornell.edu/cfr/text/21/1271.290)
- **1271.55** Sets out which records must accompany an HCT/P after the donor eligibility determination, and requires that they carry no information identifying the donor. (source: eCFR, 21 CFR 1271.55, https://www.law.cornell.edu/cfr/text/21/1271.55)
- **2 links** Where a new code is assigned to a product, procedures must relate the new code to the old one, so the chain does not break at reassignment. (source: eCFR, 21 CFR 1271.290, https://www.law.cornell.edu/cfr/text/21/1271.290)
- **820.65** The device quality system rule on traceability, which applies where an implant is a device rather than a tissue product. (source: eCFR, 21 CFR 820.65, https://www.law.cornell.edu/cfr/text/21/820.65)

## Pricing

- Single site: $450 per month
- Programme: $1,100 per month
- System: $2,400 per month

## Questions

### What is implant tissue traceability?

It is the ability to follow a human cell or tissue product in both directions: from the donor to whoever received it or to its final disposition, and from that consignee back to the donor. FDA requires a system that does this under 21 CFR 1271.290, keyed on a distinct identification code.

### What is a distinct identification code?

It is the tracking key assigned to a product specifically for tracking. The rule is explicit that it may not include an individual's name, social security number or medical record number, so it cannot simply be a patient or donor identifier reused.

### Does this replace our electronic health record?

No. The chart records the clinical event. This records the unit: where it came from, where it was held, what happened to it, and the code that ties those together. The two reference each other.

### What happens when a product is reassigned a new code?

The rule requires procedures relating the new code to the old one. The system keeps both and the link between them, so a recall against an old code still resolves.

## Sources

- [eCFR, 21 CFR 1271.290, tracking](https://www.law.cornell.edu/cfr/text/21/1271.290)
- [eCFR, 21 CFR 1271.55, accompanying records](https://www.law.cornell.edu/cfr/text/21/1271.55)
- [eCFR, 21 CFR 820.65, device traceability](https://www.law.cornell.edu/cfr/text/21/820.65)
- [eCFR, 21 CFR 820.70, production and process controls](https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec820-70.pdf)

## Contact

- office@neurobird.com
- https://neurobird.com/