510(k) · Cleared
ClearedStabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R. Thomas Grotz, M.D., Inc. · MRI Orthosis, Truncal/Orthosis, Limb
Cleared on Nov 3, 1997 as substantially equivalent to K964927 (R. Thomas Grotz, M.D., Inc., 1997) after an 81-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Nov 3, 1997
- Review
- 81 days
- Class
- Class I
- Product code
- MRI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964927 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK964927 Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor…R. Thomas Grotz, M.D., Inc. · 1997
- This deviceK973031 Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor…R. Thomas Grotz, M.D., Inc. · 1997
- Descendant · cites it directly · 0 of its ownK984200 Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and…R. Thomas Grotz, M.D., Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984200Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill…R. Thomas Grotz, M.D., Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964927 | Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture… | R. Thomas Grotz, M.D., Inc. | 1997 | — |
| 0 (this device) | K973031 | Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture… | R. Thomas Grotz, M.D., Inc. | 1997 | — |
| +1 | K984200 | Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM… | R. Thomas Grotz, M.D., Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 MRI? 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964927 | Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture Organizer, 8MM… Our OCR of the scanned summary read K964297, FDA’s number for N-Assay Tia C4 Test Kit (Crestat Diagnostics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stabilizer Soft Tissue Anchor, 8mm”. | 1997 |
| Kept off the family tree | K092670 | FDA’s K092670 is Biodrive Micro Screw System Our OCR of the scanned summary read K092670, which FDA decided on Nov 19, 2009, after this device was decided (Nov 3, 1997), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. | 2009 |
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 |
|---|---|---|---|
| K984200 | Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill… | 1999 | 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?
How does its category compare?
All MRI devicesMRI Orthosis, Truncal/Orthosis, Limb: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRI
FDA has decided no MRI device since 2007.
Median 510(k) review, days · MRI
Too few MRI 510(k)s in any year since 2007 to give a median.
Recalls per year · MRI
No recall names MRI since 2007.
Adverse event reports per year · MRI
1in 2025
MAUDE reports naming product code MRI, 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 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stabilizer Soft Tissue Anchor is a stainless steel implant intended for use as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
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/K973031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973031: Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973031
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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