510(k) · Cleared
Recalled · Class II · 2016Heritage Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 9, 1997 after a 150-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jan 9, 1997
- Review
- 150 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963109 Heritage Hip SystemZimmer, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK982812 G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963109 | Heritage Hip System | Zimmer, Inc. | 1997 | — |
| +1 | K982812 | G2 Total Hip System Femoral Stem (11/13 Taper) | Johnson & Johnson Professionals, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | — | Charnley-Type Total Hip Prosthesis Named without a submission number | |
| * | — | ZCH Hip Prosthesis Named without a submission number | |
| * | — | Longevity™ Monoblock Hip Prosthesis Named without a submission number |
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 |
|---|---|---|---|
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper) | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-1168-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Oct 11, 2013 | Class II | Z-1029-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Aug 28, 2013 | Class II | Z-0277-2014 | Packaging process control | Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982812 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures. The indications for total hip arthroplasty are: 1. Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. 2. Patients with congenital hip…
Read the full statement (177 words)
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures.
The indications for total hip arthroplasty are:
1. Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
2. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
3. Patients suffering from disability due to previous fusion.
4. Patients with previously failed endoprostheses and/or total hip components in the affected extremity.
5. Patients with acute femoral neck fractures.
The indications for hemi-hip arthroplasty are:
1. Fracture dislocation of the hip.
2. Elderly, debilitated patients when a total hip replacement is contraindicated.
3. Irreducible fractures in which adequate fixation cannot be obtained.
4. Certain high subcapital fractures and comminuted femoral fractures in the aged.
5. Nonunion of femoral neck fractures.
6. Secondary avascular necrosis of the femoral head.
7. Pathological fractures of the femoral neck.
8. Osteoarthritis in which the femoral head is primarily affected.
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/K963109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963109: Heritage Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963109
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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