510(k) · Cleared
ClearedStraight-in-Orthopedic Bone Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 1, 1999 as substantially equivalent to K982155 (Influence, Inc., 1998) and 1 other predicate after a 20-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Feb 1, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K920213 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 4 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 3 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 2 generations backK972622 Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1997
- 1 generation backK982155 Short Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1998
- This deviceK990095 Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −3 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −2 | K972622 | Straight-in Bone Screw Fixation System | Influence, Inc. | 1997 | — |
| −1 | K982155 | Short Straight-in Bone Screw Fixation System | Influence, Inc. | 1998 | — |
| 0 (this device) | K990095 | Straight-in-Orthopedic Bone Screw Fixation System | Influence, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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 MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982155 | Short Straight-in Bone Screw Fixation SystemSummary page 1…aments. The Straight-In — Orthopedic Bone Screw Fixation System is substantially equivalent to Influence, Inc.’s Short Shaft Siraight-In Bone Screw System cleared under K982155. The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are th… | 1998 |
| * | K971282 | Anchorlok and Anchorlok RL Soft Tissue Anchor SystemSummary page 1…ures, while the predicate device is designed for single use. The Orthopedic device is substantially equivalent to the Anchorlok™ Soft tissue anchor system cleared under K971282 with respect to intended use and performance of the bone screws. Information and performance testing provided and referenced in… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 3 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K982155.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as: 1. Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or…
Read the full statement (164 words)
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures.
It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
1. Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
2. Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
3. Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
4. Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
5. Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
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/K990095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990095: Straight-in-Orthopedic Bone Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990095
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