510(k) · Cleared
ClearedGRAVITYTM PEEK-OPTIMA Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 23, 2017 as substantially equivalent to K141011 (Wrightmedicaltechnologyinc, 2014) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Feb 23, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971282 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971282 Anchorlok and Anchorlok RL Soft Tissue Anchor SystemWrightmedicaltechnologyinc · 1997 · Recalled
- 2 generations backK100579 G-Force TI Suture Anchor SystemWrightmedicaltechnologyinc · 2010 · Recalled
- 1 generation backK141011 G-Force Gen 2 Suture Anchor SystemWrightmedicaltechnologyinc · 2014
- This deviceK170265 GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971282 | Anchorlok and Anchorlok RL Soft Tissue Anchor System | Wrightmedicaltechnologyinc | 1997 | 10 |
| −2 | K100579 | G-Force TI Suture Anchor System | Wrightmedicaltechnologyinc | 2010 | 2 |
| −1 | K141011 | G-Force Gen 2 Suture Anchor System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Wrightmedicaltechnologyinc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K141011 | G-Force Gen 2 Suture Anchor SystemSummary page 5…ion fastener - Class II Device Product Code and Panel Code: Orthopedics/87/MBI/HWC Predicate Device: Predicate - G-FORCE® Gen 2 Ti Suture Anchor System (K141011) G-FORCE® Ti Suture Anchor System (K100579) G-FORCE® Suture Anchor System (K100630) DEV… | 2014 |
| * | K100579 | G-Force TI Suture Anchor SystemSummary page 5…Orthopedics/87/MBI/HWC Predicate Device: Predicate - G-FORCE® Gen 2 Ti Suture Anchor System (K141011) G-FORCE® Ti Suture Anchor System (K100579) G-FORCE® Suture Anchor System (K100630) DEVICE INFORMATION A. DEVICE DESCRIPTION The GRAVITYTM PEEK-OPT… | 2010 |
| * | K100630 | G-Force Peek Suture Anchor SystemSummary page 5…G-FORCE® Gen 2 Ti Suture Anchor System (K141011) G-FORCE® Ti Suture Anchor System (K100579) G-FORCE® Suture Anchor System (K100630) DEVICE INFORMATION A. DEVICE DESCRIPTION The GRAVITYTM PEEK-OPTIMA® Suture Anchor System is a sterile, single-use, hand-hel… | 2010 |
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 20 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2017, this device’s year, is highlighted.
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 GRAVITY PEEK-OPTIMA® Suture Anchor System is indicated for use: • In the 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; • In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; • In the repair…
Read the full statement (218 words)
The GRAVITY PEEK-OPTIMA® Suture Anchor System is indicated for use:
• In the 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;
• In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
• In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
• In the 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;
• In the 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, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
o Achilles reattachment/reconstruction
o Flexor Digitorum Longus Transfer
o Flexor Hallucis Longus Transfer
o Extensor Hallucis Longus Transfer
o Brostrom Procedures
o Peroneal Tendon Relocation
o Capsule Repair
o Deltoid reconstruction / reattachment
o Plantar Plate Repair
o Spring Ligament Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170265: GRAVITYTM PEEK-OPTIMA Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170265
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