510(k) · Cleared
ClearedXenform Soft Tissue Repair Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tei Biosciences, Inc. · PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Jun 10, 2005 as substantially equivalent to K020455 (Tei Biosciences, Inc., 2002) after a 31-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Jun 10, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- PAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921895 (1992). 8 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- This deviceK051190 Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060984 Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| 0 (this device) | K051190 | Xenform Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2005 | — |
| +1 | K060984 | Xenform Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020455 | Tissuemend Soft Tissue Repair MatrixSummary page 2…ivalence is Being Claimed Xenform is substantially equivalent in function and intended use to: Predicate Devices Manufacturer 510(k) Number . TissueMend TEI Biosciences K020455 Summary of Technological Characteristics and Biocompatibility Xenform Soft Tissue Repair Matrix is substantially equivalent to o… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060984 | Xenform Soft Tissue Repair Matrix | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K060984 (Tei Biosciences, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K020455.
How does its category compare?
All PAJ devicesPAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAJ
FDA has decided no PAJ device since 2007.
Median 510(k) review, days · PAJ
Too few PAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PAJ
No recall names PAJ since 2007.
Adverse event reports per year · PAJ
2in 2019
MAUDE reports naming product code PAJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 61 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 0 | — | 0 | 286 |
| 2016 | 0 | — | 0 | 267 |
| 2017 | 0 | — | 0 | 96 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051190: Xenform Soft Tissue Repair Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051190
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026